SUMMARY:
-
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
NB! This job is now closed. You can apply for other jobs by uploading your CV.
