RA/QA Manager (Pharmaceutical Company) - Johannesburg …

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 ethicsCertificate 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 activitiesSamples/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 1974Aid 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 specificationEnsure 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 appropriateAssist 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 requirementsAssist 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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