Quality Assurance Pharmacist
3 weeks ago
We are seeking a highly skilled and detail-oriented Quality Assurance Pharmacist to join our team in Midrand, Gauteng. The successful candidate will oversee all key elements of the Quality Management System (QMS), ensuring compliance with GxP regulations and driving a culture of continuous improvement in quality standards across the organization.Key ResponsibilitiesQuality AssuranceReview, revise, and authorize all departmental SOPs.Manage QA functions including document control, Site Master File, Quality Manual, and Quality Policy.Implement and maintain the Validation Master Plan and approve/manage supplier lists.Oversee internal and external audits and ensure deviations are followed up.Manage non-conformances, deviations, OOS, ADRs, RCA, CAPA, and Change Controls.Conduct process and method validations, Product Quality Reviews, and Quality Management Reviews.Ensure effective pest control programs and technical quality agreements with third-party contractors.Implement Stability and Quality Risk Management plans.Complaints & RecallsEnsure all product quality complaints are properly identified, investigated, and resolved.Maintain full batch traceability for all distributed medicines and ensure invoices include batch numbers.Returned / Rejected GoodsEnsure returned and rejected goods are handled, recorded, and resolved in line with procedures.Authorize the re-analysis, re-packing, or destruction of returned/rejected goods.GMP / GWP / GHPConduct inspection audits to ensure compliance with GMP and manufacturing procedures.Confirm that product quality meets specifications and is maintained during storage and transport.Oversee proper destruction or disposal of medicines to prevent health hazards.Ensure pest control, temperature control, and maintenance logs are in place and monitored.Perform internal audits and ensure deviations are addressed.Audit all external service providers per the relevant procedures.Oversee quarantine, sampling, and product release processes.Approve release of final packaged products for distribution.Ensure ongoing GMP training for all employees.TrainingMonitor and ensure all departments are fully trained in GxP and approved SOPs relevant to their roles. Qualifications & ExperienceEducation:B. Pharm degreeRegistered with the South African Pharmacy CouncilExperience:Minimum of 5 years Quality Assurance experienceStrong background in SOP and QA documentation controlThorough understanding of the South African regulatory environmentKnowledge & Skills:Excellent computer literacyKnowledge of cGxP regulationsBilingual: English and AfrikaansStrong communication and analytical skillsEthical, detail-oriented, and deadline-drivenCustomer-focused and able to work under pressureTeam player with strong organizational skillsTo ApplyPlease email your updated CV in Word format, along with a copy of your Qualification/s, ID, Reference letters or contactable referees, and a profile picture of yourself to: 📧
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