Aspen Vacancies

To apply, click on the link at the end of the posts and all the best with your applications.

1. SHE OFFICER (Port Elizabeth)
2. Project Manager (JHB North)
3. Pharmacovigilance Scientist (JHB North)
4. Medical Information and Compliance Lead (JHB North)
5. Business Analyst (Epping)
6. Quality Assurance Inspector (Epping)
7. Contract Production Pharmacist (Port Elizabeth)
8. IT Developer (Woodmead) (JHB North)
9. Production Pharmacist Assistant (Port Elizabeth)
10. National Key Account Manager (JHB North)
11. Process Operator Grade 3 (Epping)

SHE OFFICER (Port Elizabeth)

Description

Overview

▪ Develop, implement, and maintain the Aspen Pharmacare SHE Management System

Responsibilities

Measuring & monitoring, Risk assessments, Incident investigations, Internal auditing, Emergency Response & Operational Controls

▪ Co-ordinate hygiene surveys, as well as environmental monitoring (effluent & storm water), sign off survey reports and co-ordinate corrective and preventative actions
▪ Calibrate and use of hygiene meters for preliminary measurements
▪ Coordinate and review issue based, and site risk assessments and co-ordinate corrective and preventative actions identified
▪ Conduct pre-commissioning inspections and provide input into projects
▪ Initiate, support and document the incident investigations and co-ordinate corrective and preventative actions
▪ Co-ordinate, conduct and track Internal SHE System audits and co-ordinate corrective and preventative actions
▪ Ensure emergency procedures, contingency plans and recovery plans are updated and implemented as directed
▪ Plan, conduct and co-ordinate emergency response drills and co-ordinate corrective and preventative actions
▪ Co-ordinate and review operational controls as per ISO standard, main activities being chemical evaluation of new molecules and waste management

Policies, principles, Group SHE Standards & legal requirements

▪ Create, edit and review of SHE procedures, work instructions and standard forms in conjunction with interested and affected parties
▪ Maintain legal appointments
▪ Co-ordinate and implement Group SHE Standards

Safety & SHE performance

▪ Conduct trend analysis for SHE performance indicators
▪ Co-ordinate and document SHE Objectives/ CI initiatives for the site
▪ Conduct standard training, as required

Asset/ Resource coordination

▪ Provide input into required changes in resources to enable achievement of own objectives; determine and request resource needs of own area of work
▪ Monitor the use of assets and resources within own area of responsibility

Reporting & record keeping

▪ Provide information for completion of reports
▪ Complete and consolidate standard documents
▪ Maintain and update records, systems and portals as required

Requirements

Skills Required

Background/experience 

▪ 2-4 years’ experience
▪ Trade Tested Artisan/ National Diploma in SHE or related

Specific job skills

▪ Risk assessment
▪ Incident investigation
▪ Internal auditing

Competencies

▪ Managing Performance
▪ Following Procedures
▪ Customer Awareness
▪ Organisational Citizenship

Project Manager (JHB North)

Reference Number

PMSC18062024

Description

COMPANY DESCRIPTION

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.

Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9,100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE:

The Project Manager in the Supply Chain Division will oversee and coordinate various supply chain projects to ensure timely delivery, cost-efficiency, and adherence to regulatory standards. This role requires strong project management skills, a deep understanding of supply chain processes, new product launch processes, and the ability to collaborate with cross-functional teams.

KEY RESPONSIBILITIES:

Project Management

• Lead and manage supply chain projects from initiation to completion, ensuring they meet business objectives and regulatory requirements.
• Develop detailed project plans, including timelines, budgets, resources, and risk management strategies.
• Coordinate with internal departments (e.g., procurement, manufacturing, logistics, quality assurance) to ensure seamless project execution.
• Monitor project progress, identify potential issues, and implement corrective actions to keep projects on track.
• Communicate project status, updates, and key milestones to stakeholders and senior management.
• Analyze supply chain processes to identify opportunities for improvement and implement best practices.
• Ensure compliance with industry regulations, company policies, and quality standards.
• Prepare and present project reports, performance metrics, and post-project evaluations.
• Manage relationships with external partners, suppliers, and vendors to optimize supply chain operations.
• Foster a collaborative and proactive project management culture within the team.

Stakeholder Engagement

• Build and maintain strong relationships with internal and external stakeholders, including suppliers, partners, and regulatory agencies.
• Collaborate with commercial teams to align supply chain strategies with business goals and market demands.
• Act as a point of contact for supply chain-related inquiries and issues.

Compliance and Quality Assurance

• Ensure all supply chain activities comply with relevant regulatory requirements and quality standards.
• Implement and monitor compliance programs to uphold the highest standards of quality and safety.

Requirements

EDUCATIONAL QUALIFICATIONS & EXPERIENCE:

• Bachelor’s degree in Supply Chain Management, Business Administration, Engineering, or a related field. A Master’s degree or PMP certification is a plus.
• Minimum of 5 years of experience in project management within the supply chain or pharmaceutical industry.
• Proven track record of successfully managing complex projects with multiple stakeholders.
• Strong understanding of supply chain principles, practices, and technologies.
• Excellent organizational, analytical, and problem-solving skills.
• Proficiency in project management software (e.g., MS Project, Asana, Trello).
• Ability to work under pressure and meet tight deadlines.
• Exceptional communication and interpersonal skills.
• Knowledge of regulatory requirements in the pharmaceutical industry is highly desirable.

SKILLS AND ATTRIBUTES:

• Excellent problem solving capability
• Strong understanding of project management
• Skills to effectively resolve conflicts in a team environment and with non-Aspen entities
• Strong leadership skill to guide business decision making considering service, cost and cash. 
• Ability implement and streamline process to support the supply chain.
• Ability to implement performance monitoring, tracking and improvement
• Performance driven and solution orientated 
• Strong analytical and numerical skills a must
• Strong technical skill in MS Office, especially excel
• Highly collaborative, flexible and attention to detail
• Excellent communication skills with the ability to liaise across all levels, excellent cross function and collaboration skills required
• The motivation and ability to create, implement and drive new processes is essential.
• Ability to influence and drive cross functional deliveries 
• Proven accountability and success with multiple tight deadline deliverables
• End to end understanding of Supply Chain operations in Plan, Source, Make and Deliver. 
• Deep understanding of S&OP and particularly supply planning contribution, key KPI and parameters. 
• Strong understanding of new product launch process within Supply Chain
• Effective oral and written skills to communicate technical and non-technical issues to various levels of management.
• Flexibility to adapt to a fast moving and international environment
• Excellent interpersonal skills and a high degree of customer focus
• Proactive approach, action oriented with the ability to solve problems and set priorities

KEY COMPETENCIES:

• Strategic Thinking: Ability to see the big picture and align projects with business goals.
• Leadership: Capable of leading cross-functional teams and driving project success.
• Detail-Oriented: Strong attention to detail to ensure project deliverables meet high standards.
• Adaptability: Flexibility to adapt to changing priorities and business needs.
• Problem-Solving: Proactive approach to identifying issues and implementing solutions.

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 26 June 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen

Pharmacovigilance Scientist (JHB North)

Reference Number

AP-4802

Description

COMPANY DESCRIPTION:

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.
Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.
The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE: To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approvals from SAHPRA and other Regulatory Authorities of the SADC member states within the committed timeframe. 
The role undertakes responsibility for compliance with the Regulatory / Pharmacovigilance Requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan. 
To provide support to the Pharmacovigilance Lead for the various Pharmacovigilance operations, in particular the medical and scientific functions with respect to safety evaluations of all Aspen products across Pharmacare and any other entity owned by Aspen, of the Aspen Group for which marketing authorizations are held. The role undertakes responsibility for coordinating and management of review and analysis of aggregate safety data concerning the Aspen Group product portfolio.

KEY RESPONSIBILITIES

Key Accountabilities

• Delegated tasks from RA Manager or PV Lead on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
• Functional reporting: Mentoring of the Pharmacovigilance Officers and Medical Writers.
• Review and advice regarding relevant local and global guidelines, policies, internal procedures and SOPs across Aspen Pharmacare.
• Maintain awareness of Pharmacovigilance regulatory requirements and developments.
• Manage outsourced data collection, organisation and preparation with vendors. 
• Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports, labelling etc.) responsible for oversight and coordination of tasks related to the area of expertise.
• Preparation of annual as well as ad-hoc and scheduled aggregate safety reports.
• Ensure Good Documentation Practice.
• Contribute to agreed PV Team quality and compliance targets.
• Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs.
• Direct interaction with Regulatory Authorities.

Financial

• Identification of project challenges to departmental line management and the financial impact thereof.
• Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective.

Medical Writing Accountabilities

• Work in collaboration with Medical Writers to write clinical documents for submission to regulatory authorities, including but not limited to:
  • clinical overviews and summaries
  • integrated summaries of safety and efficacy
  • Clinical Expert Statements
• Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
• Ensure document content and style adheres to SAHPRA/FDA/EMA or other appropriate regulatory guidelines and complies with Aspen SOPs and style guidelines.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

Safety

• ICSR (Individual Case Safety Reports)
  • Ensure all cases are processed, medical reviews completed, and cases submitted to Health Authorities as per the timelines specified in the guidelines.
  •  Ensure quality checks are performed on weekly, monthly, quarterly and bi-annual reconciliations with internal and external stakeholders.
• Labelling
  • Updating and reviewing Product Information in line with the Company Core Data Sheets, and other tasks as designated.
• Aggregate Reporting
  • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
• Risk Management System
• Preparation of Risk Management Systems including but not limited to Risk Management Plans and Risk Communication Plans.
• Requests for Information (RFIs) from Competent Regulatory Authorities (CRAs) and Safety Communications (Dear Healthcare Professional Letters (DHCPLs))
• Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
• Literature Reviews
  • Monitor local literature for designated products and identify safety issues/ ICSRs in a timely manner.
• Signal detection
• Coordinate and prepare appropriately for signal management meetings.
• Signal Management Activities including compilation of Signal Assessment Reports/ Case
  • Series Reviews for potential signals.
• Creation and update of Safety Data Exchange Agreements (SDEAs).

Training

• Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials 
• Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
• Maintain a high and up-to-date level of product and therapy area knowledge by attending conferences, training courses, reading relevant medical and scientific literature

QMS

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
• Creation and update of SOPs/WIs for all pharmacovigilance activities related to the job role in line with Pharmacovigilance regulations/guidelines (EU, ZA and other territories applicable), within specified/SOP timelines.

General

• Adhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the PV function while upholding Aspen core values
• Effective management and utilisation of resources to keep processes cost effective
• Collating data for ad hoc requests
• Adherence to Company Health & Safety procedures
• Participate in training programmes
• Any other duties as assigned by your Manager

Requirements

EDUCATION & EXPERIENCE

• B. Pharm is a requirement.
• Documented experience in all aspects of pharmacovigilance is an inherent requirement and not negotiable.
• 3-5 yrs. pharmaceutical experience with specific focus areas in PV/Drug Safety.
• Experience working with safety databases.
• Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PBRERs is preferable.
• Experience in writing RMPs is desirable.
• Experience working with MedDRA coding dictionary.

KNOWLEDGE

• Strong knowledge of regulatory and medical authorities in South Africa
• Strong understanding of regulations, ICH guidelines, and GCP
• Extensive medical writing and expertise in submissions

SKILLS AND ATTRIBUTES

• Results and performance driven – deliver results that meet or exceed expectations
• Integrity
• Work ethic 
• Ability to meet deadlines
• Sense of urgency – responding to issues and opportunities in a timely manner
• Intellectual curiosity – willing to suggest and try new ideas
• Positive and pro-active approach to business tasks
• Excellent interpersonal and communication skills
• A solutions provider
• Manage evolving deadlines effectively with regular feedback and updates
• Enthusiasm and drive to take ownership and drive process initiatives
• Service orientation
• Customer focused
• Logical thinking
• Information seeking
• Positive ‘can – do’ attitude
• Be able to work autonomously and have good problem-solving skills
• Able to cope with evolving deadlines effectively with regular feedback and updates
• Honest and trustworthy
• Respectful and highly personable
• Possess cultural awareness and sensitivity
• Flexibility & confidentiality are key requirements for this role.

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 01 July 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen

Medical Information and Compliance Lead (JHB North)

Reference Number

AP-4806

Description

COMPANY DESCRIPTION:

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.
Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.
The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE: To support the SA Commercial Business to realise the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in South Africa and the South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.

The role undertakes responsibility for coordinating and managing the Medical Information and Compliance requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the management and implementation of the South African and SADC Regulatory Plan for a defined portfolio of products. This includes all Regulatory Authority requirements relating to Medical Information and Compliance for Aspen and Alliance Partner products, ensuring that adequate procedures and systems are in place for the activities to be carried out at Pharmacare in line with global and local regulations.

To ensure Aspen Pharmacare’s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa and the South African Development Community (SADC) region.
To ensure growth and sustainability of Aspen Pharmacare’s SA and SADC product portfolio within the legislative framework of the respective countries and in compliance with the company strategy.

To provide support to and manage tasks from the Regulatory Affairs Manager: Safety, Quality and Compliance, Pharmacare or HOD or Executive on a defined and/or ad hoc basis. To provide leadership, training and support to the Medical Information and Compliance team.

KEY RESPONSIBILITIES:

MEDICAL INFORMATION
Responsible for:

• Overseeing the running of the Medical Information function for Aspen Pharmacare and contractual partner products.
• Creating procedures to ensuring compliance with global regulations, ensuring consistent standards and timely responses.
• Liaising closely with internal stakeholders including Pharmacovigilance, Regulatory and Quality.
• Monitoring line listing for missed Adverse Events and Product Complaints.
• Providing regular metrics to share with relevant internal stakeholders including Pharmacovigilance, Regulatory and Quality.
• Ensuring that the Medical Information function maintains a comprehensive bank of Standard Responses (SRs).
• Developing relationships with partners to share knowledge and best practice.
• Set up knowledge management systems, access to literature, reference textbook and implement data protection.
• Training pharmacovigilance personnel in handling medical information enquiries as back up.
• Acting as a primary point of contact and ensuring that adequate support is provided in a timely manner to Medical Information service providers/distributors/ affiliates/complainants in responding to medical information enquiries.
• Ensuring that relevant process is set up between Medical Information and contractual partners (including APTL) on communication of medical information enquiries to Aspen Pharmacare.
• Ensuring information and reviews obtained are reverted back to the Complainant/Affiliate/Distributor/Medical Information service provider within the agreed timelines per affiliate.
• Ensuring that relevant metrics report received from Medical Information /distributor/affiliate is reviewed and provide regular feedback.
• Ensuring that Affiliate/Distributor/Medical Information service provider is adhering with Aspen’s policy in providing scientific support to internal and external customers.
• Actively increasing awareness of Medical Information services to colleagues and customers in appropriate ways.

REVIEW OF PROMOTIONAL AND NON-PROMOTIONAL MATERIAL
Responsible for:

• Ensuring that staff, systems and processes are in place for the review of promotional and non-promotional material.
• Creating, reviewing, approving and training objection handlers to commercial staff.
• Ensuring that staff, systems and processes are in place for the review of promotional and non-promotional material.
• Reviewing and approving promotional material relating to the advertising and promotion of medicines and related products for the SA and SADC markets in compliance with applicable legislation, codes of practice and any other applicable regulations/guidelines and corporate requirements.
• Liaising with marketing divisions regarding advice, queries, and timelines in relation to the above.
• Assisting with the review of information relevant to each product.
• Attending promotional campaign concept presentations at the request of the marketing teams to provide regulatory support and input.
• Overseeing the generation of monthly reports for incomplete and expiring promotional material documents and liaising with the commercial team to ensure that any outstanding actions regarding these documents are addressed.
• Assisting the commercial team and the IT support team with any system requirements or queries as they arise.
• Overseeing the running of monthly reviewer statistics for the Medical Information and Compliance team.
• Receiving the MIMS OTC, Monthly MIMS (Pharma and Consumer) and MDR and coordinating the reviews for the business.
• Providing guidance and support to the Medical Information and Compliance team members on promotional and non-promotional material reviews.

PRINTED PACKAGING/ARTWORK
Responsible for:

• Ensuring that staff, systems and processes are in place for the review of packaging artwork.
• Overseeing the review and approval of concepts of new or updated artwork/printed packaging material for medicines and related products for the SA and SADC markets in compliance with applicable legislation and corporate requirements.
• Providing guidance and support to the Medical Information and Compliance team members on artwork reviews.

AFRIKAANS TRANSLATION OF PROFESSIONAL INFORMATION (PI) AND PATIENT INFORMATION LEAFLETS (PILs)
Responsible for:

• Ensuring that staff, systems and processes are in place for the translation and validation of Afrikaans PIs and PILs.
• Ensuring that translations are managed accurately and timeously.

MAINTENANCE OF MI/PV TELEPHONY SYSTEM
Responsible for:

• Ensuring good working collaboration with Aspen IT for maintenance of the MI/PV Telephony system.
• Ensuring that staff and processes are in place for managing incoming calls and after hour calls.
• Ensuring the testing of the telephony system as per company procedures

IMPLEMENTATION AND MAINTENANCE OF THE SA REGULATORY PORTAL (REGULATORY DOCUMENTS AND SAHPRA PI/PIL REPOSITORY)
Responsible for:

• Ensuring that staff, systems and processes are in place for uploading of the current approved PI/PILs, DHPLs, Recall letters, training material, Section 21/36 communiques and medically critical list to the SA Regulatory Portal.
• Ensuring that staff, systems and processes are in place for uploading the current approved PI/PILs to the SAHPRA PI/PIL Repository (or equivalent platform).

SECTION 21/36 SUBMISSIONS
Responsible for:

• Ensuring that staff, systems and processes are in place for submission and approval of Section 21/36 applications.
• Ensuring that the internal and external customers are informed of Section 21/36 approvals.

CLINICAL DUE DILIGENCE AND CREATION OF PIs/PILs/CCDSs
Responsible for:

• Ensuring that staff, systems and processes are in place for creation and reporting on clinical due diligence.
• Ensuring the timely creation of PIs/PILs to be included in the new submissions for dossiers to be submitted to SAHPRA.
• Ensuring that CCDSs are created as required.
• Ensuring the timely response to clinical evaluation recommendations (CERs).

MEDICALLY CRITICAL LIST
Responsible for:

• Ensuring that a bi-annual review of the medically critical list is initiated.
• Ensuring that the final approved medically critical list is uploaded to the SA Regulatory Portal.

IMPLEMENTATION OF RISK MANAGEMENT PLANS (RMPS)
Responsible for:

• Ensuring that a full understanding is gained with regards to the implementation of approved and updated RMPs.
• Ensuring that RMP material is created and reviewed by a validated system.
• Ensuring that the commercial team is trained in the requirements of the RMP roll-out prior to distribution of material.
• Ensuring that the RMP reporting requirements/effectiveness checks are implemented.

PROJECT MANAGEMENT
Responsible for:

• Providing assistance with any specific projects and operational support for the Medical Information     
  and Compliance team.

TEAM MANAGEMENT
Responsible for:

• Creating ways of doing things differently and more effectively within the department.
• Challenging current ways of working with a view to suggesting more effective and efficient processes.
• Accomplishing staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
• Keeping the team apprised of important information.
• Providing any other operational support for the Medical Information and Compliance team.
• Supporting the continuous development and improvement of the Medical Information and Compliance functions while upholding Aspen core values.

QUALITY MANAGEMENT SYSTEM
Responsible for:

• Ensuring systems and procedures are in place in accordance with the Medical Information and Compliance team’s requirements and that these are maintained according to the relevant SOPs.
• Ensuring compliance of the Medical Information and Compliance team with all company SOPs and policies.
• Ensuring departmental readiness for any internal or external audits.
• Ensuring accurate and ‘real-time’ filing of training records.
• Ensuring ‘real-time’ maintenance of TrackWise/QAlign records.
• Ensuring that relevant documentation requested by auditors is provided in a timely manner during internal and external audits.
• Ensuring that training records are up to date to ensure audit readiness.
• Ensuring that the commercial team members are trained in those RA:SQC procedures where there are shared responsibilities.

FINANCIAL
Responsible for:        

• Effective utilisation of resources to keep processes cost effective.
• Adhering to the RA Department’s budget and forecasts.

GENERAL
Responsible for:

• Overseeing and ensuring relevant records are maintained as soft copies and hard copies as per Aspen Pharmacare’s filing structure/ instructions.
• Informing management of important issues as they arise which require their attention.
• Adhering to Company Health & Safety procedures.
• Participating in training programmes. 
• Any other relevant duties as assigned by the manager.
• Adhering to agreed Key Performance Indicators (KPIs).
• Supporting the continuous development and improvement of the Medical Information and Compliance function while upholding Aspen core values.

Requirements

EDUCATION & EXPERIENCE:

• Bachelors or Post Graduate degree in science, pharmacy or medicine
• Minimum 3 – 5 years’ experience in the pharmaceutical industry in medical information or a similar field
• Management or supervisory experience
• Facilitator training experience
• Experience working with remote teams
• Experience in medicine legislation and related guidelines and codes of practice
• Experience in promotional material and artwork review
• Clinical trial experience advantageous

KNOWLEDGE:

• Regulatory Authority requirements
• Medical Information
• Information Source Material
• Information Management
• Product knowledge
• Industry knowledge
• Dossiers and requirements
• Knowledge of appropriate legislation
• Understanding of the laws and requirements governing the marketing of medicines and printed packaging
• Guidelines and Codes of Practice
• Knowledge of relevant information sources including printed publications, unpublished sources, databases, websites, social media sites and external bodies
• Effective understanding and use of the principles of information capture, storage, searching and retrieval
• Effective use of appropriate IT systems and programs
• Ability to communicate information effectively and clearly in written form and orally, and at levels appropriate to the needs of different internal and external customers
• Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, PV Regulations
• Understanding the needs and priorities of the customer

SKILLS AND ATTRIBUTES:

• Interpersonal skills
• Integrity and good work ethic
• Self-starter
• Ability to meet deadlines
• Planning skills
• Time management skills
• Problem solving
• Analytical skills
• Communication skills
• Initiative
• Confidentiality
• Customer focused
• Patience
• Influence
• Accuracy and attention to detail
• Logical thinking
• Information seeking
• Sense of urgency
• Use of effective questioning to establish and understand requests
• Effective organisation skills and ability to prioritise
• Ability to work under pressure and to tight deadlines
• Ability to work in a fast-paced international environment
• Information Management
• Ability to manage projects in a matrixes team environment and with
  both internal and external partners
• Willing to travel if required
• Presentation skills
• Service orientation
• Decision making skills
• Interpersonal sensitivity and skills
• Self-confidence
• Organisational awareness
• Empathy
• A solutions provider
• Manage evolving deadlines effectively with regular feedback and updates
• Enthusiasm and drive to take ownership and drive process initiatives

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 03 July 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen

Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their applications

Business Analyst (Epping)

Reference Number

Business Analyst01

Description

Fine Chemicals requires the services of a highly competent Business Analyst for the ISV Department. To qualify for this position suitable candidates must fulfill the following requirements.

Requirements

JOB REQUIREMENTS:

• IT degree / suitable SAP qualification
• A minimum of 5 years working experience with SAP s4 HANA in industries such as manufacturing, assets management, sourcing and procurement, Supply chain management
• In-depth knowledge of SAP, preferably in the areas related to manufacturing and quality environments
• SAP ECC experience is advantageous
• Experience with Power BI, Power Automate, and other AI capabilities are advantageous
• Must have knowledge and experience with lifecycle management using solution manager
• Thorough knowledge of GxP and computer system validation
• Must have knowledge of manufacturing business processes and organisation, application landscape, and IT standards (ITIL, COBIT)
• Must have the ability to identify opportunities and transform them into quantifiable and achievable initiatives
• Proven ability to create business requirements, business processes, and project plans
• Must be able to create business cases, operating models, and financial models

BASIC JOB FUNCTIONS (Brief Summary):

• The Business Analyst serves as the liaison between IT, IT partners, and inter-group.
• Is responsible for identifying the business needs to help determine and implement IT solutions according
  to IT guidelines.
• Collaborates with business stakeholders and functional areas to capture, assess, and challenge business
  requests into clear requirements.
• Works closely with third-party vendors including software providers, implementation partners, and
  consultants to help develop and implement the IT solution, fulfilling business needs (integration with thirdparty
  systems)
• Is responsible for functional application management and addressing SAP-related incidents and problems
• Participates in system and user acceptance testing efforts
• Assists business liaisons to evaluate cost-benefit and ROI analyses
• Leads business change initiatives with responsibility for the overall implementation of an IT project or program managing scope, cost, and schedule
• Builds standards, processes procedures, and guidelines for business liaisons.

PERSONAL ATTRIBUTES (Brief Summary):

• Meticulous attention to detail
• Excellent communication skills both verbal and written
• Must be able to work under pressure and be part of a team or work independently at times
• Be able to communicate with both senior management team as well as end users in a non-technical
  manner
• Demonstrates interpersonal skills required to successfully work in a team environment and communicate
  effectively across various stakeholder groups.  

Suitably qualified applicants are invited to submit their CV’s online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Quality Assurance Inspector (Epping)

Reference Number

QAInspector123

Description

Fine Chemicals requires the services of a highly competent and experienced QA Inspector for the Quality Assurance Department.  To qualify for this position the most suitable candidate must fulfill the following requirements.

Requirements

JOB REQUIREMENTS:

·        A tertiary qualification – National Diploma/BTech in Quality or BSc Chemistry or Life Sciences

·        GMP experience – knowledge of ICH and FDA guidelines for API manufacturers and their application, and relevant Quality system certification

·        Must be computer literate, MS Windows, i.e., Word, Excel, PowerPoint, etc.

·        Validation, Regulatory, and Production experience will be advantageous

BASIC JOB FUNCTIONS (Brief Summary):

·        Carrying out site audits

·        Document/report writing, reviewing, issuing, and change control

·        Preparing the site for external audits and Regulatory Inspections

·        Verification of validation activities within the nominated manufacturing area

·        Producing and checking labels for raw materials, intermediates, and finished goods according to the set standard operating procedures and master schedule of standard labels

·        Checking the issuing of tamper-evident packaging components according to the set procedure

·        Ensuring production complies with cGMP, the BPR instructions, and all related SOPs

·        Reviewing BPRs and raising deviations where necessary

·        Assisting with the batch release procedure

·        Maintaining the electronic databases related to the batches released

·        Maintaining relevant filing systems that ensure traceability of the position’s functions

·        Investigating and documenting deviations

·        Participating in root cause analysis and CAPA identification

·        Understanding and complying with all relevant SOPs

·        Facilitate training in compliance with cGMP

·        Performing internal audits

·        Collate data as required to support the successful execution of validation studies

·        Consult with Procurement and QC on Raw Material related matters to ensure BOM requirements are met, and Compliance issues attained (approval of suppliers)

·        Provide ad hoc support to NPD Tech Transfer projects, legacy product re-location and validation

·        Participate and review Risk Assessments as required

·        Perform QA review of Regulatory statements/declarations

PERSONAL ATTRIBUTES (Brief Summary):

•     Observation – ability to observe and evaluate processes and procedures

·        Excellent organisational and administrative skills

·        Excellent problem-solving skills

·        Attention to detail – proofreading and auditing

·        Ability to communicate with all levels of the business

·        Ability to interpret regulations and take initiative

·        Confident to address adverse issues at all levels of the business

·        Good interpersonal skills

·        Ability to apply critical thinking to arising situations/scenarios 

Suitably qualified applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws apply to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Contract Production Pharmacist (Port Elizabeth)

Reference Number

CPPUnit1

Description

• Monitor manufacturing compliance to GMP and statutory requirements.
• Monitor adherence to guidelines, procedures, and document controls.
• Deliver expected productivity targets as per business requirements.
• Related administrative tasks.
• Serve as back up to Team Leader on shift.

Requirements

Planning and Procedures

• Plan and prioritize daily, weekly, and monthly activities
• Determine, request, and use resources/ assets optimally

Inspections and Verifications

• Verify schedule 5 products
• Verify certified clean status of rooms and equipment
• Verify, review, and approve verification of measuring equipment performance, calibrations, and sampling, and dispensing of materials

Line & Production processing

• Perform, review, and approve line sign-on’s, closures and clearance authorizations
• Perform, review, and approve batch reconciliations to product specifications and quality
• Ensure production process adherence to standards and specifications

Process and system improvements

• Manage, review, and approve change control programs and deviations/ concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimize processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus

Compliance & Auditing

• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Review and approve preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions, and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new Pharmacists and PMAs on SOPs in transition period
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution

Skills required

Background/experience

• Minimum of bachelor’s degree preferred, ideally in Pharmacy
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience
• Registration with Pharmacy Council

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Information gathering
• Interrogating information
• Meeting deadlines
• Finalizing output
• Taking action

IT Developer (Woodmead) (JHB North)

Reference Number

AP-4839

Description

COMPANY DESCRIPTION

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high-quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.
Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.
The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE: To ensure that efficient and cost-effective business solutions and processes are in place to address business needs/requirements. This role will work closely with the other teams, assist in designing, developing, testing and maintaining software solutions. 

KEY RESPONSIBILITIES:

Management of IT Service Delivery and Support

• Create, analyse, and validate detailed functional specifications
• Design, Build and implement relevant software solutions / Applications
• Facilitate design sessions with implementation teams to define solutions
• Testing of Solutions / Applications
• Share knowledge with other Teams

 Stakeholder / Customer delivery

• Collaboration with clients / stakeholders to gather and understand business requirements
• Provide Application support and training for clients
• Train clients /stakeholders on new and existing Applications
• Build Stakeholder relationship

Innovation

• Identify current and future state business processes
• Drive business enabled innovation using technology
• Assess and refine existing processes, and develop new where necessary, to support the strategic direction of the organization

IT Governance 

• Formulate technical requirements specification based on business requirements
• Assess and remediate any security vulnerability that may exist in technology

Requirements

QUALIFICATION AND EXPERIENCE:

Qualifications

• Matric / Grade 12
• Diploma / Degree in Information Technology field or equivalent work experience (+2 years) in an Information Technology environment
• Experience in Service management environment / Supporting the user Community and key stakeholders with proven experience of service support in a matrix approach with internal and external resources which may not be direct reports

Experience

• Experience in the developing solutions using Microsoft Power Platform MS PowerApps, Flow, Power Automate, Microsoft Forms
  Knowledge Power BI
• Knowledge of Sharepoint Administration, ServiceNow
• Microsoft Office 365 knowledge is essential
• Ability to design database models
• Ability to facilitate interactive design and technical specification sessions
• Ability to work with all levels of the organization, both technical and non-technical
• Sound knowledge of methodologies & frameworks such as Agile, SDLC, Waterfall
• Knowledge of ERP system – SAP

Competencies

• Excellent analytical and technical skills 
• Communicate effectively
•  Facilitation
• Integrity & Honesty
• Customer Focused
• Persistence, Patience
• Innovative
• Results oriented
• Effective Problem solving and troubleshooting
• Accuracy & attention to detail.
• Self-development orientation.
• Dedication.
• Self Confidence.
• Assertiveness.
• Logical & Lateral thinking.
• Information Seeking.
• Persuasive, negotiation 

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 23 July 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen

Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their applications

Production Pharmacist Assistant (Port Elizabeth)

Reference Number

PMAUN1M

Description

• Monitor and report on manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures, and document controls
• Related support and administrative tasks

Requirements

Inspections and Verifications

• Perform visual inspections of rooms, machine parts and equipment
• Verify that rooms and equipment are certified clean as per SOP
• Verify scale and measuring equipment performance and daily
• calibration as per SOPs, protocols, and schedules
• Verify daily sampling, dispensing of materials and its mass/ volume
• Perform housekeeping of rooms and equipment

Line & Production processing

• Perform line sign on and closure
• Check and authorize packaging line clearance
• Order and maintain substance materials
• Perform batch reconciliations to product specifications and quality
• Monitor production process in line with standards and specifications

Process and system improvements

• Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
• Manage and resolve customer complaints
• Optimize processes and identify gaps in policies/ procedures

Compliance & Auditing

• Conduct shift GMP checks and ensure continued compliance
• Conduct environmental checks and check expiry dates of agents
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Check preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new PMAs on SOPs
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required

Skills Required

Background/experience

• Post Basic registration as Pharmacist Assistant with Pharmacy Council
• 1-3 years’ Pharmacist Assistant experience
• Pharmaceutical manufacturing experience advantageous

Specific job skills

• Basic technical knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Interrogating information
• Meeting deadline
• Finalizing outputs
• Maintaining accuracy

National Key Account Manager (JHB North)

Reference Number

AP-4841

Description

COMPANY DESCRIPTION

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.

Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE: Will be responsible for managing Key Accounts via driving and implementing Key Account Operational Plans aligned to the Strategic and Tactical Business Portfolio Plans. The successful incumbent will have customers across the FMCG segment such as Pharmacy Wholesalers and Pharmacy customers (not limited to) that include much growth potential. Drive achievement of sales budget for Consumer division, managing net revenue, operating income and trade expenditure. You will be required to collaborate and work cross-functionally and inter-departmental with Marketing, Sales, Finance, Supply Chain, Legal, Compliance and 3rd Party Logistics. Ensure the adherence to Aspen policies, systems and procedures.

KEY RESPONSIBILITIES:

• Ensure all financial and non-financial objectives are achieved for Key Accounts as set by the Consumer Head in collaboration with the KAM Lead. 
• Plan, implement, execute and monitors sales activities to drive performance on a national and regional territories.
• Be accountable and drive goals and objectives that are channel specific that include and not limited to Pharmacy, Retail and Pharma Wholesaler. 
• Work closely with Finance and Debtors Team managing Operating Expenses and Debtors’ Management.
• Liaise with finance and legal department in coordinating and negotiation of trading agreements and expenditure tracking and management.
• Identify and develop new business opportunities in both sales channel and product portfolio.
• Ensuring all strategic negotiations become operationally visible through daily interaction and communication with sales, marketing teams and management.
• Prepare and manage budgets according to operational requirements and robust expenditure management.
• Monthly achievement & reporting on budgets
• Methods for improving customer services are proposed, developed and continuously updated.
• Ensure Aspen remains partner of choice in key product categories.
• Implement improvement in services and products via execution of channel-specific tactics.
• Ensuring adherence to legislations, the Self-Care Association marketing Code and Aspen’s values, policies and procedures

Requirements

EDUCATION & EXPERIENCE:

• Matric Certificate.
• A degree/ diploma / courses in relevant commercial/ healthcare environment (Advantageous).
• Min 3-5 years Sales / Marketing / Key Accounts management experience.
• Experience in setting and strategizing of account budgets, strategies, and tactics incl. Forecasting.
• Experience in customer negotiations i.e., Trade / Contracts etc.
• Strategic Market understanding and knowledge – essential.
• Substantial expertise and proven Customer Relationship Management.
• MS Excel proficiency on advanced level.

KNOWLEDGE: 

• Knowledge of FMCG landscape across various key account channels
• Knowledge of processes
• Policy and procedure
• Customer data analytics
• Finance knowledge
• System knowledge
• Product knowledge
• Industry knowledge
• Future trend analysis
• Strategic marketing
• Pharmaceutical Laws i.e., Pricing / Marketing

SKILLS:

• Planning skills
• Time management
• Problem solving
• Budgeting
• Forecasting
• Analyzing trends
• Service orientation
• Decision making skills.
• Interpersonal skills
• Strong Customer Relationship Management
• Communication skills
• Self-Motivated
• Negotiation skills
• Leadership skills

ATTRIBUTES:

• Initiative
• Accuracy
• Confidentiality
• Customer focused.
• Interpersonal sensitivity
• Logical thinking
• Information seeking
• Enquiring mind
• Self-development orientation
• Cultural sensitivity
• Vision
• Integrity
• Planning and organizing
• Analytical
• Decision making
• Commercial astuteness
• Ability to handle pressure.
• Negotiation skills
• Entrepreneurial spirit
• Persuasive
• Ability to delegate
• Flexible and strategic thinker

Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CV online on or before the 25 July 2024. Preference will be given to applicants from designated groups through a fair recruitment and selection process in accordance with laws governing employment equity, where such laws are applicable to the Aspen

Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their applications

Process Operator Grade 3 (Epping)

Reference Number

ProcessOperatorGr3

Description

Fine Chemicals requires the services of a Grade 3 Process Operator for the Operations Department. To qualify for this position the candidate must fulfill the following requirements:

Requirements

JOB REQUIREMENTS:   

• Matric/Grade 12 with mathematics and science
• Must have an aptitude for process understanding and working with your hands  
• Must have the ability to be trained and of good health
• Must be willing to go on formal Chemical Operator training
• Previous operator experience in manufacturing plant would be advantageous but not a requirement.BASIC JOB FUNCTIONS               
• To become conversant in the operation of production equipment/machines according to set procedures and work instructions.
• Understand and comply with all relevant SOP’s and work instructions.
• To follow instructions as guided by either the Team Leader or Supervisor.
• Performs regular housekeeping duties to ensure a clean and healthy work environment according to current good manufacturing practices (cGMP) requirements.
• Understand and comply with relevant health, safety, and environmental procedures whilst performing his/her duties.

PERSONAL ATTRIBUTES

• Good communication skills
• Must be able to work and perform under pressure in a highly regulated environment
• Must be numerate and show attention to accuracy
• Must be willing to work shifts and overtime as operationally required 

Suitably qualified applicants are invited to submit their CV’s online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Click here to apply

All the best with your applications.