Amd Group Leader

2 weeks ago

Cape Town, Western Cape, South Africa Biovac Full time

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous AMD Group Leader to join a goal-oriented team.

Qualifications Needed:

  • Preferably PhD or MSc with at least 5 years experience in relevant discipline.

Necessary Skills & Industry Knowledge:

  • 5 years experience in vaccine / biotech / pharmaceutical industry or equivalent would be advantageous.
  • 2 years supervisory experience in product development or a cGMP environment.
  • Exposure and understanding of scientific principles that governs production of vaccines and /or biologicals.
  • Quality & regulatory compliance knowledge, i.e. SAHPRA and WHO.
  • GDP and IP management knowledge preferable.
  • Experience in technology transfer would be advantageous.
  • Knowledge of cGMP (SA, PIC, WHO) and GLP guidelines.
  • Experience in having faced successfully local quality audits would be an advantage.
  • Experience in Analytical Method Development, Qualification, Verification and Validation is preferable.

Key Duties & Responsibilities:

  • Laboratory Administration including Budgeting and Cost Control (Assists with group/ unit budgeting, follows a cost conscious culture within own department/ group/ unit).
  • Ensure services are delivered to all internal and/ or external stakeholders as defined and as per agreed timelines.
  • Risk and Anticipation Mitigation to ensure that all work done is in accordance with current standards/processes and assist Senior Scientist/Scientist to identify anticipated risks impacting group/ unit/ team.
  • Follow cGMP guidelines and ensure all Change Controls/ NCRs etc. are effectively managed to support QAs processes.
  • Close all actions assigned to self/ staff member as per EHS committee agreed deadlines.
  • Responsible for providing assistance, guidance, problem solving or input to the operational departments as required and agreed.
  • Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines.
  • Responsible for Analytical Method Development (microbial, immunological, chemical).
  • Responsible for experimental design, planning, execution, problem solving and recording.
  • Accountable for specified deliverables within projects according to agreed timelines.
  • Assist with technology transfers from development to manufacturing (including manufacture of material to be used in clinical trials).
  • Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines.
  • Driving Innovation and Continuous Improvement.
  • Driving Quality Risk Management.
  • Managing Deviations, Change Controls, CAPAs.
  • Quality Objectives: Drive the quality objectives.
  • Ensure a timely and effective communication.
  • Escalate quality issues to the appropriate levels of management.


By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who form part of the process.

Application Deadline: 01 March 2023.

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