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Cape Town City Centre: Responsible Pharmacist

Cape Town City Centre: Responsible Pharmacist

Posted on 2025-04-30 00:00:00

Employer Unspecified
Category Scientific / QA
Location Cape Town Region  / Cape Town City Centre

Job Summary

Are you a seasoned pharmacist with a passion for cutting-edge biopharmaceuticals? Afrigen Biologics & Vaccines is looking for a meticulous and driven Responsible Pharmacist to lead regulatory compliance, uphold Good Manufacturing Practice (GMP) standards, and ensure the safe and effective production of vaccines at our world-class facility. This pivotal role demands technical expertise, strategic oversight, and a relentless commitment to quality and safety in a high-stakes environment focused on global health innovation. Key Responsibilities: Compliance and Regulatory Oversight Ensure full compliance with the Medicines and Related Substances Act, Pharmacy Act, and applicable SAHPRA/SAPC guidelines. Maintain and renew relevant licenses and certificates, including submission of updated Site and Pharmacovigilance Master Files (SMF/PSMF). Prepare for and lead external inspections and audits. Quality and Risk Management Oversee the implementation and maintenance of a robust Quality Management System (QMS). Supervise batch review and product release/rejection processes. Manage non-conforming product incidents including complaints, recalls, and waste handling. Ensure an effective Pharmacovigilance (PV) system, including agreements, data integrity, continuity planning, and staff training. Operational Leadership Conduct self-inspections, root cause analysis, and implement corrective actions. Identify and address trends through structured management reviews. Monitor and report compliance risks to senior leadership and regulatory authorities where required. People and Facility Management Ensure proper registration, training, and delegation of pharmacy staff in accordance with the Pharmacy Act. Supervise access control and adherence to SOPs, especially for scheduled substances and finished goods. Engage proactively with internal and external stakeholders to maintain seamless regulatory and operational alignment. Qualification Bachelor of Pharmacy (B.Pharm) degree Registered with South African Pharmacy Council (SAPC) Minimum 5 years’ experience in the pharmaceutical industry Prior experience as a Responsible Pharmacist and/or within Quality Assurance or Regulatory Affairs is strongly advantageous Strategic thinking, problem solving skills, and the ability to lead a dynamic, regulated environment

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