Knowledge, Skills and Attributes:
- Problem solving; analytical skills; service orientation; decision making skills; interpersonal skills; report writing skills; attention to detail; initiative; confidentiality; customer focused; logical thinking; information seeking; sense of urgency; computer literacy
- Work independently as well as in a team, possess strong written and verbal communication skills, and have sound work ethics
- Certificate or higher in health sciences, biomedical technology, business administration, or equivalent qualification
- Experience in Quality Assurance and/or Regulatory Affairs in a pharmaceutical environment would be advantageous
The main purpose of this position:
Quality Assurance function - To assist in all necessary functions to ensure company compliance with sound Quality Assurance principles, Good Manufacturing Practice and regulatory requirements relating to the warehousing/distribution of medicines in South Africa, including the product complaint reporting process, product release, internal and external audits and relevant training.
Duties & Responsibilities:
Regulatory Affairs Function
- To assist in product lifecycle management
- Day-to-day RA tasks
- Compilation of minor variation responses
- Updating of PI and PIL leaflets to follow latest SAHPRA guidelines
- Liaising with various departments and regulatory bodies
- Administrative activities
- Samples/Courier services – local & international
- Co-ordination of intellectual hard copy material for off-site storage
- Co-ordination of on-site shredding services of confidential documents
General
Ensure compliance to:
- SAHPRA for compliance with the requirements of the Medicines and Related Substances Act 101 of 1965
- Pharmacy Council for compliance with the requirements of the Pharmacy Act, 53 of 1974
- Aid and support Health Safety & Environmental compliance
- All activities will be under the supervision of a pharmacist
Quality Assurance Function
- Release of imported and locally manufactured products
- Review batch manufacturing, packaging, and laboratory documentation to ensure that production controls, production conditions and results of testing comply with the procedure and finished product specification
- Ensure that batch traceability is maintained for all products (recall procedure)
- Request and review annual product quality reviews
- Trending of local data for all products
- Management of reference samples as well as retention samples
- Ensure that additional sampling, inspection, tests, and checks are carried out or initiated, as appropriate
- Assist in the decision-making of rejected goods, materials, and components.
- Managing & maintaining the Quality Management System
- Setting up and facilitating management review meetings
- Handling and actioning non-conformances
- Implementing CAPA’s (Corrective Actions & Preventative Action)
- Identify and implement improvement opportunities
- Review, update, and maintain master documents, standard operating procedures, and release and batch manufacturing documents
- Responsible for the internal and external audit plan, inspections, reports, and reviews according to the SOP requirements
- Assist and manage statutory inspections from SAHPRA, SAPC, and DOH
Review and update the Site Master File as well as the Quality Manual.
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