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QA Manager (Port Elizabeth)
Reference Number
QAManagerSVP3Feb25
Description
Overview
Develop, manage, and monitor quality procedures, standards and specifications for value streams in compliance with regulations. Manage and monitor core QA activities for value streams. Review and approve in-process QA programs and activities. Manage and guide the unit through team leaders. Performance management of direct reports and units.
Responsibilities
Planning and Processes
- Interpret, implement, and coordinate systems, processes, policies, and procedures contributing to the quality assurance in the unit.
- Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations and quality in the unit.
- Attend L2-3 meetings.
Financial and Resource management
- Provide input into the functional financial plan / budget based on operational requirements.
- Ensure availability and optimal allocation of resources within unit.
People Management & Development
- Implement human resource policies.
- Participate in training, coaching and development for team members.
- Develop and implement performance contracts and succession plans.
- Manage conflict, disciplinary and safety issues.
- Assist with recruitment.
Product Release
- Lot release and/or rejection of starting materials, packaging materials, intermediate, bulk and finished products.
- Review and approve process to release disposition of products.
- Determine batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
- Perform batch release when required.
Process Compliance
- Review and approve CAPA plans to address systematic issues
- Review and approve operational changes to SOPs and processes.
In process Quality Management
- Review and approve for in process quality management
- Ensure effective review and monitoring of supplier management system
Governance, Risk & Compliance
- Participation in management reviews and escalation of quality issues
- Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS.
- Review and approve document retention procedures
Requirements
Background/experience
- Minimum of bachelor’s degree (B pharm) preferred
- 7 years related work experience.
- Pharmaceutical manufacturing experience
Specific job skills
- Strong working knowledge of pharmaceutical manufacturing and corrective action programmes.
- Pharmaceutical standards and compliance requirements
- People management
- Ability to interpret and implement policies, procedures, and objectives
QC Team Leader (Port Elizabeth)
Reference Number
QCTLSVP3FEB
Description
Overview
Manage and co-ordinate lab preparation and QC activities. Manage and co-ordinate sampling and testing of external environment. Provide analytical, maintenance and QC lab support. Ensure continuous compliance of lab with GMP standards. Ensure that products are produced, tested, and stored according to the required SOPs and documentation. Performance management and of direct reports.
Responsibilities
Planning and Section Management
- Provide input into operational planning of section, and prioritization of objectives.
- Provide input into, interpret, and execute policies and procedures.
- Provide input into and manage budgets and resource requirements for section.
- Provide section staff with day-to-day direction and tasks.
QC Lab Testing
- Manage and monitor compliance of QC lab testing activities to GMP, quality standards and product specifications.
- Manage and co-ordinate lab preparation activities according to SOPs (samples, working area(s), PPE, and lab equipment.)
- Prepare and implement maintenance and calibration schedules and records.
- Ensure set priorities and targets are achieved, identifying constraints and solutions.
- Investigate and report Out of Specifications (OOS).
- Enforce Good Lab Practice.
Environmental Managing
- Manage and co-ordinate sampling and testing of external environmental, according to SOPs and sampling plan/schedule.
Lab Quality Reviews & Training
- Validate batch documentation approvals.
- Review and approve corrections in batch documentation.
- Identify and coordinate training of staff of SOPs.
Deviations Investigations
- Manage and coordinate deviation investigations and reporting.
- Coordinate and initiate risk/ impact assessments and plans to address quality deficiencies.
- Manage implementation of operational changes to SOPs and processes.
Governance, Risk and Compliance
- Provide input to QC for improvement of risk-based compliance systems.
- Monitor implementation and correct own and / team compliance with legislation, policies and procedures.
Requirements
Background/experience
- Bachelor’s degree in chemistry / microbiology with 5 years of related experience.
- Laboratory and Good Laboratory Practice experience.
- Supervisory experience.
Specific job skills
- Advanced understanding of pharmaceutical testing methods.
- Knowledge of value chain and MCC principles.
- Understanding of pharmaceutical manufacturing and corrective action programs.
- Pharmaceutical standards and compliance requirements.
- Ability to interpret and implement policies, processes, and objectives
Responsible Pharmacist & QA Manager (Epping)
Reference Number
RP Pharmacist/QA Manager
Description
Fine Chemicals requires the services of a Responsible Pharmacist & QA Manager. To qualify for these positions the most suitable candidates must fulfill the following requirements
Requirements
JOB SPECIFICATIONS:
- Minimum requirement BPharm Degree
- A minimum of 3-5 years of Manufacturing and Quality experience is needed
- A minimum of 5-10 years of Management experience in Pharmaceutical, API, or medical device manufacturing facilities.
- Must have 3-5 years of Management/Supervisory experience
- Must be registered with the Pharmacy Council
- Must have completed Internship & Community Service
- Must have experience in validation processes and requirements
- Must have internal and overseas vendor auditing experience.
- Sound knowledge of GMP regulations (European, US, UK, WHO, PICS).
- Knowledge of other pharmaceutical and scientific standards (ICH, Pharmacopoeia etc.)
- Knowledge and understanding of Quality Management Systems in pharmaceutical and related industries.
- Must have had exposure to international pharmaceutical practices.
- Knowledge of engineering systems as relates to utilities and equipment in facilities.
- Sound knowledge of manufacturing products and processes.
- Knowledge of packaging technology is an advantage.
- Microbiological experience would be advantageous
- Product registration experience would advantageous
- Computer proficiency in MS Office and SAP.
BASIC JOB FUNCTIONS (Brief Summary)
- SAHPRA Permit Applications
- Obtaining the necessary permits for import and export of Specified Schedule 5 and Schedule Substances.
- Host customer and regulatory audits on behalf of Fine Chemicals.
- Technical, supply, and quality agreements are completed accurately and timeously.
- Ensure annual renewal takes place with the South African Pharmacy Council (SAPC)
- Ensure that Management Review (QSMR)of the Quality System is conducted periodically.
- Suitable systems exist for the management of SOPs, change control, deviations are investigated and resolved, CAPA is raised where appropriate, and review and approval of all quality-related documents.
- Systems are managed to ensure compliance with standards in QSMR meetings.
- Establish policies and procedures concerning acts performed and services provided in the company relating to scheduled substance.
- Ensure that there is an effective system for the release/rejection of all APIs/intermediates for use outside the control of FCC.
- To ensure legal compliance to all Acts, i.e. the Pharmacy Act (Act No 53 of 1974, as amended) and the Medicines and Related Substance Control Act (Act 101 of 1965, as amended)
- To carry out the duties of a Responsible Pharmacist in accordance with Regulations 28 of the Pharmacy Act
- To act responsibly in the practice of pharmacist in accordance with operational requirements of the business
- Initiate, compose, implement, and regularly update all documentation related to the Quality Unit.
- Train appropriate personnel in SOP’s and other relevant areas.
- Administer and conduct internal audits.
- Participate in the batch release process by ensuring adherence of products to GMP guidelines.
- Manage and maintain the Quality Management System.
- Manage and control staff and other resources as required to meet the objectives of the Quality Unit and FCC.
- Adhere to and promote compliance with H&S regulations.
- Conduct supplier audits and participate in vendor management processes.
PERSONAL ATTRIBUTES (Brief Summary)
- Good organizational skills, proven leadership skills, and self-driven.
- Exceptional attention to detail and accuracy.
- Excellent report writing and document reviewing skills.
- Uncompromising individual integrity and work ethic.
- Exercise interpersonal skills, communication, training, and problem-solving skills to optimize team performance.
- Demonstrate initiative and apply advanced concepts
- Proven leadership skills, self-driven and motivated.
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.
Market Access Lead (JHB North)
Reference Number
AP-5175
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 OF ROLE
Co-ordinate all internal and external market access and reimbursement activities for Aspen’s product portfolio to enable commercial success.
KEY RESPONSIBILITIES
- Develop market access plans for specified products in line with product brand plans
- Create tailored payer solutions, leveraging Aspen’s resources and appropriate resources from payer partners and third parties when applicable
- Engage external payers/Medical aids to ensure optimal access and reimbursement for Aspen and partner products
- Establishes trust-based relationships with private and public payers to identify their key needs potential areas for strategic collaboration.
- Acts as Payers’ single point of contact and representative of all Aspen’s products across business units.
- In Payer negotiations, has the mandate to make decisions on the product value and price level
- Ability to develop business cases to address current payer pain points.
- Develop product business cases to determine go-no-go decisions for Aspen and Alliance partners
- Provides leadership and subject matter expertise on the changing healthcare dynamics and the needs of the payer customer. Proactively shares best practices and leverages synergies across Business Units
- Co-develops strategies across Aspen’s business units that identifies relevant customer needs, prioritizes initiatives and company investments, and establishes a clear action plan for success.
- Manage the internal Aspen process to ensure optimal market access for products as per their life cycle, in line with brand plans and timings
- Actively generates payer insights and ensures the inclusion thereof in Aspen’s strategic planning processes
- Utilizes payer landscape insights and knowledge to help refine the go-to-market strategies and value proposition development across Aspen’s product portfolio
- Conduct price/volume scenario analysis to support price decision making on behalf of the business
- Assists the broader organization in developing Aspen’s capability in payer partnerships in an Affordability Constraint market
Requirements
EDUCATIONAL REQUIREMENTS
Bachelor’s Degree required
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 3-5 years Market Access experience
- Demonstrated ability to launch new products with optimal patient access and reimbursement
- Market access or commercial experience in immunology and oncology therapeutic areas
- A solid understanding of the SA healthcare landscape, regulations and pricing dynamics
- Deep technical knowledge of pricing processes and developing business cases for NCE’S
- Financial modelling understanding in terms of developing robust business cases and assumptions
SOFT SKILLS REQUIREMENTS
- Customer Centricity (Internal and external)
- Fluency in uncertainties driving payer decision making
- Fluency in Financial planning, Risk Management and Funding mechanisms
- Strong Analytical skills
- Negotiation skills
- Strategic thinking
- Judgement
- Interpersonal leadership
- Learning agility
COMPUTER SKILLS REQUIRED
Proficient in Microsoft Office Suite with a focus on Excel and Power BI
The successful candidate must have a valid driver’s licence and be available to travel as per the requirements of the role.
Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 12 February 2024. Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.
Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application for this specific role.
Human Capital Intern (JHB North)
Reference Number
AP-5169
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 careers 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.
Requirements
This Internship is for a fixed period of 12 months during which learners will be exposed to practical and theoretical knowledge of Human Resources. It is envisaged that field trips will form part of the curriculum as such learners must be willing and be able to travel. Must not have participated in a Learnership or Internship programme.
To be considered for this opportunity, applicants must meet these minimum requirements:
- Must have a completed Degree/BCom in Human Resources or Industrial Psychology
- Must be proficient in Microsoft Office Suite
- South African Citizen
- No current or pending disciplinary incidents
Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 04 February 2025 . Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.
Paralegal: Commercial and Affiliates (Durban North)
Reference Number
Paralegal17012025
Description
JOB PURPOSE
To take responsibility for and ensure efficient and effective secretarial, administrative and paralegal support to the allocated lawyers in the legal team (“Legal Team”) for maximum output in the delivery of quality business aligned legal services by the Legal Team, including facilitating and acting as an intermediary between the Legal Team and internal / external stakeholders including law firms. To undertake substantive legal work including preparation of first drafts and first legal review of standard agreements for the Legal Counsel, documenting and taking responsibility for workflow of legal matters generally through the electronic Legal practice management system (“FMS”). To take responsibility for and manage allocated matters from inception to resolution under supervision from the Legal Counsel. Preparing and managing efficient and accurate reporting.
KEY PERFORMANCE AREAS
1. Core Legal Work
- Specialised Aspen and Business Unit (“BU”) aligned general legal work in the Legal Team under guidance of the responsible Aspen Lawyer.
2. Paralegal Expertise
- Efficient and accurate paralegal expertise including drafting, first comments, file management, project and matter co-ordination, management of deliverables and reporting.
3. Legal Management Administration
- Efficient and accurate Legal practice management, electronic file creation and management, electronic document retention, contract management via the electronic Aspen Contract Library (ACL), electronic reporting and certain general administration including processing invoices.
4. Cross-Swimlane Projects
- Meaningfully contribute and deliver ancillary legal work in Group Legal cross – swim lane projects, as allocated by the Group Executive: Legal.
5. BU Allocated Responsibility
- Group Legal BU Allocated Responsibility, including:
- Template creation, improvement and management.
- From time-to-time BU administration allocated by the Group Executive: Legal.
6. Group Legal BU KPI
- Meet (or exceed) and manage Group Legal BU KPI.
7. Aspen Values & personal Insights
- Adopt and comply with the ways of working within the Aspen Group Legal BU, including specifically the Aspen Values and honest application of personal Insights® Profile (or similar from an Aspen Group service provider) to enhance interpersonal effectiveness.
Requirements
EDUCATION:
- Matric / Grade 12 and recognised professional paralegal qualification, or university degree or sound progress towards a university degree, which is preferable
CERTIFICATIONS/REGISTRATIONS:
- Registration with appropriate qualification body
OVERALL EXPERIENCE:
- 5 years demonstrated experience in performing a senior legal secretary and or paralegal function, some of which has ideally been at an in-house legal department
SPECIFIC EXPERIENCE, KNOWLEDGE AND REGISTRATIONS:
- Exposure to working with long, complex legal agreements essential
- Familiarity with legal terminology essential
- Relevant experience in a legal practice or corporate environment essential
- General commercial understanding and exposure
- Advanced legal sense; systems; pharma product knowledge and industry understanding an advantage
WORK-SPECIFIC SKILLS & EXPOSURE:
- Essential to have expertise in Microsoft Office, particularly advanced MS Word such as automatic numbering & cross-referencing (including table of contents and bookmarking), track changes, comments in different formats, document security & protection, comparisons and combinations, etc; digital signatures, advanced Excel such as formatting, headings, filters, linking between sheets and workbooks, conversions, etc; and advanced Powerpoint
- Database establishment and management, including transaction virtual data rooms (“VDRs”)
- Project management / co-ordination of deliverables and trackers
SKILLS AND ATTRIBUTES:
- An above average natural affinity to accuracy of work
- Advanced PC literacy on all MS Word applications (including Windows, PowerPoint, Outlook and Excel)
- Ability to decide, action and assess priorities and when to execute
- Minimum typing speed of 75 wpm
- Verbal and written proficiency in the English language
- Methodical implementation skills
- Administrative and organizational skills
- Electronic database establishment and management
- Positive, diligent and hard worker
- Ability to prioritise and co-ordinate work
- Flexible, outcomes-based, self-motivated and proactive
- Project management / co-ordination / monitoring of deliverables and trackers
- Ability to accurately monitor and manage spend against a financial budget
COMPETENCIES:
- Ability to plan & organise independently and deliver, including securing input and guiding others
- Initiating action, follow up and time management
- Stakeholder focus and outcomes-based approach
- Quality orientation
- Decision-making
- Stress tolerance and conflict resolution
- Problem-solving and analytical skills
- Service-orientated
- Extreme accuracy and attention to detail is a pre-requisite
- High level of integrity, ethical values and confidentiality
ASPEN COMPETENCIES
Business:
- Performance Driven
- Accountability / Ownership
- Make Good Decisions
People:
- Deals with Ambiguity/ Embraces Change
- Communicates Effectively and Respectfully irrespective of status
Self:
- Contributes special paralegal expertise
- Takes action with Integrity
- Willing and able to work as a team including taking and providing guidance
Aspen is committed to the principles of equal employment opportunity. Preference will be given to applicants from designated groups through a fair recruitment and selection process in line with Aspen’s Transformation Agenda.
Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.
If you have not heard from the HC department within 30 days of this advert closing, please consider your application unsuccessfu.
Microbiologist (Port Elizabeth)
Reference Number
MicrobiologistSVP_Jan2025
Description
Overview
- Perform microbiological tests on raw materials, water, cleaning and environmental samples, in-process and final products to ensure quality and compliance
- Review compliance of documentation according to pharmaceutical standards
Responsibilities
Planning and Operational Support
- Optimise and facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Propose changes or improvements to processes, tools and techniques
Microbiological Testing
- Perform microbiological tests on raw materials, in-process and final products to ensure quality and compliance with GMP standards
- Test water according to SOPs and testing schedule
- Notify Production of source of any contamination timeously
- Develop and implement plans to control level and source of contamination
Environmental Management
- Perform sampling and testing of external environment, according to SOPs and sampling plan/ schedule
Quality Control
- Report OOS results and deviations immediately
- Manage frequency of testing and sampling to maintain a quality process
- Maintain good housekeeping
- Manage and coordinate the use, maintenance and calibration of testing equipment according to SOPs
- Ensure continuous compliance of laboratory with GMP standards
Reporting and Record-Keeping
- Document and store data according to SOPs and regulation
- Consolidate information for reports on weekly/ monthly basis
- Analyse consolidated data and provide recommendations
- Compile detailed and standardised reports and consolidated documents
Requirements
Skills Required
Background/experience
- National Diploma in Microbiology
- Microbiological laboratory experience with 6+ years experience
Specific job skills
- Advanced knowledge of microbiological testing methods
- Understanding of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
Brand Manager – CNS & Dermatology (Woodmead) (JHB North)
Reference Number
AP-5123
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 OF ROLE
Drive sustainable, profitable growth of the product portfolios/ therapeutic categories with appropriate strategic direction, brand stewardship and commercial acumen.
KEY RESPONSIBILITIES
The primary tasks, functions and deliverables of the role:
- Strategic Decision making
- Market analysis and insight
- Develop portfolio/brand strategy for sustainable business growth and profitability
- Successful implementation and monitor the roll out of the above with the required measurements in place for successful outcomes
- Anticipate future trends in disease management and the market environment
- Commercial capability
- Ability to set sales budgets and manage
- Ability to manage Advertising and Promotion budgets and ROI impact
- Compile and manage advertising budget and spend
- Ability to manage the cross functional networks and channel resources for the portfolio to drive profitable growth with the required and shared accountability to achieve business targets
- Ability to interpret and implement insights drawn from a variety of internal and external data sources as result of the required interactions
- Forecasting accuracy and stock management which entails minimizing write-off costs and returns, monitoring and managing wholesalers’ stock holding and backorders
- Maintaining portfolio profitability through pricing strategies, profit margins and batch MOQ’s
- Accurately assess market potential by preparing product P&L’s to successfully implement new product launches
- Evaluate Congress attendance and participation to maximize ROI
- Innovative way of thinking to secure a competitive advantage
- Solution orientated
- Provide creative direction for brand/ portfolios strategies and manage Agency outcomes
- Pipeline management to secure future portfolio assets
- Sense of urgency in resolution of customer queries
- Quality assessments of portfolio/ brand strategy implementation through in field visits
Requirements
EDUCATIONAL REQUIREMENTS
- Relevant Post matric Marketing/Health Science qualification
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- Financial literacy
- Ability to work on Qlikview models is advantageous
- 2 years Pharmaceutical /Marketing industry experience
- 2-3 years brand management
- Applicable industry knowledge
SOFT SKILLS REQUIREMENTS
- Commercial acumen
- Analytical skills
- People Management
- Project management
- Networking ability
- Interpersonal skills
- Ability to perform under pressure
- Self-starter and self -motivated
- Sense of urgency and Agile
- Prioritizing and planning
- Verbal and written communication skills
- Aptitude for continuous learning
- Influential and impactful presentation skills
- Adaptability and flexibility in a changing environment
COMPUTER SKILLS REQUIRED
- Proficiency in Excel, PowerPoint, Outlook and Word
The successful candidate must have a valid driver’s licence and be able to travel as per the expectations of the role.
We wish you all the best with your applications
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