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 literacyWork 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 qualificationExperience in Quality Assurance and/or Regulatory Affairs in a pharmaceutical environment would be advantageousThe 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 FunctionTo assist in product lifecycle managementDay-to-day RA tasksCompilation of minor variation responsesUpdating of PI and PIL leaflets to follow latest SAHPRA guidelinesLiaising with various departments and regulatory bodiesAdministrative activitiesSamples/Courier services – local & internationalCo-ordination of intellectual hard copy material for off-site storageCo-ordination of on-site shredding services of confidential documentsGeneralEnsure compliance to:SAHPRA for compliance with the requirements of the Medicines and Related Substances Act 101 of 1965Pharmacy Council for compliance with the requirements of the Pharmacy Act, 53 of 1974Aid and support Health Safety & Environmental complianceAll activities will be under the supervision of a pharmacistQuality Assurance FunctionRelease of imported and locally manufactured productsReview 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 reviewsTrending of local data for all productsManagement of reference samples as well as retention samplesEnsure 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 SystemSetting up and facilitating management review meetingsHandling and actioning non-conformancesImplementing CAPA's (Corrective Actions & Preventative Action)Identify and implement improvement opportunitiesReview, update, and maintain master documents, standard operating procedures, and release and batch manufacturing documentsResponsible for the internal and external audit plan, inspections, reports, and reviews according to the SOP requirementsAssist and manage statutory inspections from SAHPRA, SAPC, and DOHReview and update the Site Master File as well as the Quality Manual.
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