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Cape Town: Responsible Pharmacist posted by Afrigen Biologics & Vaccines

Cape Town: Responsible Pharmacist posted by Afrigen Biologics & Vaccines

Posted on 2025-05-18 00:00:00

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)
  • Previous vaccine manufacturing experience would be beneficial
  • 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

Click Go Apply to apply online!

View Job  Johannesburg: Chartered Accountant posted by Goldman Tech

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