Responsible Pharmacist

SUMMARY:
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POSITION INFO:

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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