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Technical Cleaner (Epping)
Reference Number
Recruiter01
Description
Fine Chemicals requires the services of a Technical Cleaner for the Site Services. To qualify for these positions the most suitable candidates must fulfill the following requirements:
Requirements
JOB REQUIREMENTS:
- Matric / Grade 12
- Experience in cleaning and housekeeping in an industrial environment
- Qualified forklift driver or able to be trained as one
- Knowledge and understanding of chemical products and correct usage
- Must have high safety, health, and hygiene standards
- Must have the ability to be trained and in good health
- Must have basic operating machinery experience and hand tools
- Must be able to perform solvent drum handling, working at heights, and working in confined spaces
BASIC JOB FUNCTIONS (Brief Summary):
- All roadways and areas external to buildings, though generally do not include grass or garden areas.
- Remove and sort all solid waste to the solid waste handling area.
- Ensure that production hazardous/non-hazardous waste bins are emptied and returned regularly during the day.
- Ensure redundant reagent glass bottles from Laboratories are removed when the bin is full.
- All refuse to be taken for sorting and compaction or other.
- Assisting with office removals, transfers of files, etc.
- Collection and handling of all waste generated by Production, Laboratories, Warehouses, and Offices.
- Monitoring and cleaning of all tank and drum bunds
- Drumming and movement of waste and treated products from the Solvent Recovery System and Hazardous Aqueous Waste (HAW) treatment plant
- Charging of drummed HAW to HAW tank farm.
- Cleaning of utilities and technical equipment within production areas (ventilation ducting, utilities pipe work, scrubber ducting, and hard-to-reach process pipework)
- Cleaning of production void areas
- Cleaning of production Plant Rooms
- Assist in deep cleaning of production areas and equipment when required (e.g. annual SS vessel internal polishing, deep cleaning of SS flooring, etc.)
- Assist with site material movement where required
- Assist with general audit preparation work where required
- Assist with fire watch duties where required
- Dispensing of Raw Materials in Raw Material Stores
PERSONAL ATTRIBUTES (Brief Summary):
- Must be honest and reliable
- Able to work in a team as well as independently when required
- High attention to detail and accuracy
- Good communication skills
- Ability to work under pressure
- Able to work extended hours at short notice if required
- Must have good etiquette and interpersonal skills
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.
Business Development Lead (JHB North)
Reference Number
AP-5220
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 business development activities to build Aspen’s product portfolio in line with business strategy.
KEY RESPONSIBILITIES
- Develop a molecule wish list with targeted manufacturers to build the Aspen portfolio
- Engage international dossier suppliers and manufacturers to conclude South African agreements
- Manage existing and new partner Marketing and Distribution agreements
- Lead the negotiations and conclusion of marketing and distribution agreements with potential partners, for products/molecules that are strategic to the Aspen SA product portfolio going forward.
- Leads the internal process to finalize and conclude business development deals.
- In partnership with Legal, take ownership of term sheets and contracts, to ensure all legal aspects are covered
- Negotiate favourable terms in Marketing and Distribution Contracts and ensure swift responses during contract negotiations to ensure a deal conclusion.
- Lead and manage the internal Aspen business development process to ensure optimal business development strategy and execution
- Ensure the business development process is well defined and that the internal business owners can engage with the process effectively and efficiently
- Co-ordinates and aligns internal transversal teams to support the evaluation and negotiation of business development deals
- Enables our portfolio build ambition through utilizing: market data, business knowledge, networking, and advanced negotiation, project management and communication skills to execute successful partnership agreements across Aspen’s prescription, OTC and Consumer business.
- Present business development opportunities to the Aspen Group, in line with group expectations and local strategy
- Enable portfolio build ambition through utilizing: market data, business knowledge, networking, and advanced negotiation, project management and communication skills to execute successful partnership agreements across Aspen’s prescription, OTC and Consumer business.
- Finance Management
- Responsible for the development of profit and loss sheets for business opportunities and take ownership for the transversal management of the business development process in partnership with the finance function.
- Work with relevant teams to prepare a forecast model for the potential opportunities and implement it in line with the business expectations
- Work with the marketing, sales, finance, medical and regulatory teams to make informed decisions on the return on investment for every product opportunity
- Prepare business plans, budgets, forecast and cash flow models for new business opportunities
Requirements
EDUCATIONAL REQUIREMENTS
Bachelor’s Degree required in Healthcare/Science or Business Management
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 5+ years of Business Development experience within the pharmaceutical environment
- Demonstrated ability to in-license new products and portfolios in alliance models with international partners
- Understanding of the South African regulatory landscape and requirements, with a general understanding of GMP and GWP.
SOFT SKILLS REQUIREMENTS
- Skilful presenter / communicator of scientific and business information to executive level audiences
- Demonstrated complex transversal project management skills
- Ability to develop robust forecast models with structured underlying assumptions.
- Sound financial understanding of profit and loss statement development in pharmaceutical industry setting.
- Time management and deadline driven
- Ability to work independently, under pressure and use initiative
- Strong negotiation skills
- Knowledgeable of regulatory processes and legal documents, e.g. contracts/agreements, patent and trademark searches.
- Demonstrated cross functional working behaviours.
- Forward thinking and proactive.
- Strong networking capability.
- Results oriented
COMPUTER SKILLS REQUIRED
Proficient in the Microsoft Office Suite
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 10 March 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.
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.
Accounts Representative (Epping)
Reference Number
Accounts Representative
Description
Fine Chemicals Corporation requires the services of a highly competent individual to fill the position of Accounts Representative in the Finance Department.
Requirements
JOB REQUIREMENTS:
- Accounting Diploma or equivalent
- Minimum 3-5 years of working experience ideally within the finance department of a manufacturing environment
- Must have sound knowledge of the accounts payables and receivables environment
- A good working knowledge of Microsoft Office is essential (particularly MS Excel)
- Experience in working on the SAP ERP system would be advantageous
JOB FUNCTION (Brief Summary):
- Daily processing of received invoices (screening, scanning, and processing in VIM and SAP Allocation using 2 or 3-way or non-purchase order method
- Ensure receipts and payments are captured timeously and according to Company policy and procedures
- Liaison with internal and external suppliers and customers
- Engagement with Suppliers and Customers in a professional manner
- Resolving daily Creditor & Debtor queries
Creditors
- Process invoices daily
- Prepare monthly and intra-month creditors reconciliations
- Follow-up on Creditor related issues/queries and the tracking thereof
- Reconcile the accounts payables ledger to ensure that all invoices are accounted for and properly posted
- Monthly clearing of the GR/IR accounts
- Assist in the preparation of the month-end accounts payable age analysisDebtors
- Allocate receipts daily
- Prepare, review, and mail monthly customer statements
- Follow-up on Debtor related issues/queries and the tracking thereof
- Reconcile the receivable ledger to ensure that all payments are accounted for and properly posted
- Assist with collections of overdue accounts
- Assist in the preparation of the month-end accounts receivable age analysis Bank
- Multi-cash Download and review & multi-cash upload into SAP
- Verify allocations, postings, and clearing of transactions
- Raise invoices for Debit Orders and capture against Suppliers
- Reconcile Bank Statements to the ledger daily. Month-end reconciliation to be updated to the electronic month-end file
- Follow up on related bank queries
PERSONAL ATTRIBUTES (Brief Summary):
- Good organisational skills and deadline-driven
- Exceptional attention to detail and accuracy
- Good communication skills (written and verbal)
- Adherence to instructions and procedures
- Uncompromising individual integrity and work ethic
- Strong resistance to pressure
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.
Chemical Analyst (Port Elizabeth)
Reference Number
ChemSVPQC
Description
Overview
- Perform QC and stability tests on raw materials, in-process and finished products, components, and water to ensure quality and compliance.
- Review compliance of products to GMP, quality standards, and product specifications.
- Provide services according to Production plan.
Responsibilities
Planning and Operational Support
- Optimise and facilitate implementation of current processes.
- Propose changes or improvements to processes, tools, and techniques.
Test Preparation
- Prepare and analyse samples according to SOPs.
- Prepare and operate laboratory equipment according to SOPs.
- Perform calibration checks on equipment according to calibration procedure, to ensure accurate results.
- Prepare reagents and solutions for testing.
- Maintain good housekeeping.
Testing
- Perform HPLC/GC analysis using MOA.
- Perform routine analysis on in-process and final products, raw materials and components.
- Perform routine stability tests such as related substances, assay and dissolution to assess quality of product.
- Perform daily and weekly water testing according to SOP.
- Support testing for OOS investigations to establish any systematic issues in process or testing.
- Handle problems efficiently according to quality policy
- Report feedback on services or outputs regularly to customers
- Check HPLC/GC runs regularly during the shift.
- Provide internal customers with accurate HPLC/GC results.
- Propose, develop and update methods for improving customer service.
- Check, document and report operational output against actuals.
- Communicate deviations for production and process improvements.
- Utilise technology as per qualification requirements.
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 provided recommendations.
- Record, interpret and report testing results to management, including OOS results.
Requirements
Background/experience
- National Diploma in Analytical Chemistry with 2+ years’ experience
- Laboratory experience
Specific job skills
- Advanced understanding of pharmaceutical testing methods
- Understanding of pharmaceutical manufacturing and corrective
- action programs.
- Knowledge of Millennium Software (HPLC) and GC Software
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives.
Medical Information and Compliance Pharmacist (JHB North)
Reference Number
AP-5216
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 officesin over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.
OBJECTIVE OF ROLE
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 the South Africa and 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.
To ensure Aspen Pharmacare’s SA product portfolio complies with the related Acts and guidelines to support and maintain registration in South Africa. To ensure growth and sustainability of Aspen Pharmacare’s SA product portfolio within the legislative framework of the country and in compliance with the company strategy.
The role undertakes responsibility for compliance with the Regulatory Medical Information and Compliance 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 perform Medical Information and Compliance monitoring activities for Aspen in accordance with procedural documents and relevant governing group policies.
To meet the needs of healthcare providers and patients/consumers through collaboration with internal customers to ensure delivery of accurate and scientifically balanced medical information, and promotional and non-promotional material, and to respond to unsolicited inquiries from regulatory authorities, including clients and managed healthcare organisations in a manner that will help them make a decision regarding therapy for a patient or product selection.
KEY RESPONSIBILITIES
FINANCIAL
- Effective utilisation of resources to keep processes cost effective.
- Adhering to Regulatory Affairs budget and forecasts.
MEDICAL INFORMATION (MI)
- Providing support within the MI function in responding to labelled and off-label medical information enquiries for Aspen and contractual partners.
- Providing compliant responses to internal and external customers.
- Creating and maintaining standard responses (SRs) and Objection Handlers (OHs).
- Ensuring that the relevant department/s are informed in a timely manner (at receipt or at least within 24 hours) following the receipt of adverse events or product quality complaints/potential counterfeit medicines. This include performing a daily check on the dedicated medical information inbox and MAfax inbox.
- Ensuring that Affiliate/Distributor/MI is adhering to Aspen’s Policy in providing scientific support to internal and external customers.
- Identifying gaps and suggesting ways of process improvement in MI.
- Ensuring that the reconciliation between the Medical Information function and Pharmacovigilance and the Quality department is effective by performing ad hoc reviews on reconciliation files.
- Ensuring that any suggested improvements within the professional information and/or patient information leaflets are communicated to the PV Lead at the point of identification.
- Supporting the line manager in generation of medical information reports showing trends in medical information enquiries received.
- Managing after hour MI enquiries on a rotational basis.
- Ensuring telephony system testing documents are completed as per allocation.
- Ensuring compliance to Key Performance Indicators (KPIs) response timelines.
- Ensuring a professional attitude is displayed when responding to a customer’s needs.
PROMOTIONAL MATERIAL, SCIENTIFIC MATERIAL REVIEW AND COMPLIANCE MONITORING
- 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.
- Reviewing and approving educational, scientific and other non-promotional material 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.
- Ensuring that compliance monitoring is performed on all territories and non-compliances are escalated in a timely manner to the line manager as per Aspen group policies.
- Supporting the line manager in developing and maintaining procedural documents for compliance monitoring.
- Supporting the training department in providing recommendations for improvement and compliance with Aspen group policies following compliance monitoring review.
- Supporting the line manager in generating reports associated with compliance monitoring activities.
REGULATORY AUTHORITY SUBMISSIONS (INCLUDING SECTION 21/36):
- Performing clinical due diligence for new intellectual property as received from the regulatory function.
- Creating Professional Information (PI) and Patient Information Leaflets (PILs) for new IP.
- Creating company core data sheets.
- On time responses to clinical evaluation recommendations (CERs) and clinical screening enquiries.
- Accurate compilation and filing of the electronic submission documentation.
- Accurate completion of all tasks pertaining to submissions as specified in the relevant procedural documents.
- Maintaining tracking tools to ensure on time submission and reporting.
- Identifying process enhancements.
- Ensuring accurate uploading of the current approved PIs and PILs to the SA Regulatory Portal and submission to SAHPRA for uploading to the PI/PIL Repository (and relevant platforms).
- Managing Section 21 and 36 submissions.
IMPLEMENTATION OF RISK MANAGEMENT PLAN (RMP) MATERIAL:
- Ensuring that RMP material is created, maintained and rolled out to market.
- Ensuring that the relevant sales force team is adequately trained, and training records are filed.
- Ensuring that tracking tools are in place to ensure logging of material distribution and reporting to SAHPRA.
PRINTED PACKAGING/ARTWORK
- Reviewing and approving concept 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.
AFRIKAANS TRANSLATION OF PROFESSIONAL INFORMATION (PI) AND PATIENT INFORMATION LEAFLETS (PILs)
- Assisting with the translation and/or validation of Afrikaans PIs (where required) and PILs for both new and existing products.
- Ensuring that translations are undertaken accurately and timeously.
PROJECT MANAGEMENT
- Providing assistance with any specific projects and operational support for the MI and Compliance team
MAINTENANCEOFTHE ASPEN MEDICALLY CRITICAL LIST
- Initiating and finalising a bi-annual review of the Aspen medically critical list.
QUALITY MANAGEMENT SYSTEMS
- Maintaining procedural documents for the Medical Information and Compliance function as specified in the individual KPAs (as per identified subject matter expert/s).
- 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 on those RA:SQC procedures where there are shared responsibilities.
GENERAL
- Ensuring systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
- Adherence to agreed Key Performance Indicators (KPIs).
- Supporting the continuous development and improvement of the Medical Information and Compliance function while upholding Aspen core values.
- Ensuring relevant records are maintained as soft copies and hard copies, as per Pharmacare filing structure/instructions.
- Adherence to Company Health & Safety procedures.
- Participation in training programmes.
- To provide a leadership role as required by taking responsibility for specified areas and coaching of staff.
- Any other duties as assigned by Manager.
Requirements
EDUCATIONAL REQUIREMENTS
- Bachelor of Pharmacy Degree and registration with the South African Pharmacy Council
KNOWLEDGE AND EXPERIENCE REQUIREMENTS
- Minimum 1 to 2 years’ pharmaceutical experience
- Experience in Medical Information is an advantage
- Ability to work with multi geographical locations & time zones
- Experience in medicine legislation and related guidelines and codes of practice preferable
- Regulatory Authority requirements/legislation
- Understanding of the laws and requirements governing the marketing of medicines and printed packaging Guidelines and codes of practice
- Understanding requirements of medical information and information management
- Terminology – understanding the jargon
- Understanding business processes
- Product knowledge
- Industry knowledge
- Dossiers and requirements
- Multilingualism (including Afrikaans) would be an advantage
SOFT SKILLS REQUIREMENTS
- Integrity, good work ethic and ability to meet deadlines
- Self-starter
- Analytical and planning skills
- Accuracy and attention to detail
- Effective organisational skills and ability to prioritise
- Ability to work under pressure and to tight deadlines
- Ability to work in a fast-paced international environment
- Ability to manage projects in a matrices team environment and with both internal and external partners
- Willing to travel if required
- Presentation skills
- Time management skills
- Service orientation
- Decision making skills
- Customer focused
- Self-confidence
- Organisational awareness
- Information seeking
- Excellent interpersonal and communications skills
- A solutions provider
- Manage evolving deadlines effectively with regular feedback and updates
- Enthusiasm and drive to take ownership and drive process initiatives
- Logical thinking
- Positive ‘can – do attitude’
- Work autonomously and have good problem-solving skills
- Honest and trustworthy
- Respectful and highly personable
- Possess cultural awareness and sensitivity
- Flexibility and confidentiality
- Empathy, patience, influence
- Sense of urgency
- Positive and pro-active approach to business tasks
- Business process analysis
- Report writing
- Information gathering and monitoring
- Projects (advantage)
COMPUTER SKILLS REQUIRED
- Effective use of appropriate IT systems and programs
Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 04 March 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.
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.
We wish you all the best with your applications.
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