The Biovac Institute requires a Biological Testing Supervisor to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.

The successful incumbent will report to the QC Biological Testing Section Head.

The Key Performance Areas for this position include:

• Schedule Planning
o Fortnightly meeting with QC Planner to discuss internal QC and cross-departmental plans.
o Daily planning of analyst activities
• Progress Monitoring, Follow-Up & Reporting
• Inter-Team Synergy
• Team Weekly and Monthly Meetings; Progress Feed-back
• Performance Management
• Growth, Succession & Retention Implementation
• Co-ordination of biological and microbiological testing including sterility testing, environmental monitoring, endotoxin testing and other tests.
• Review of laboratory raw data and investigation of out of specification results.
• Compilation of analytical method validation/verification protocols and reports and co-ordination of the testing.
• Writing and updating of material and product specifications and test methods and standard operating procedures.
• Liaison with suppliers on technical issues where applicable.
• Maintaining laboratory operations at cGMP standards to ensure quality, safety and regulatory compliance.
• Ordering and stock control.
• Adherence to QA quality system requirements e.g. CAPAs, deviations, change controls.
• Participation in quality audits.
• Coordination of laboratory support activities (including cleaning of glassware, autoclaving, waste disposal and specialized cleaning of graded areas).
• Review of autoclave logs and approval of autoclave cycles.
• Transformation
• Team Budgeting and Expense Management
• Sectional Risk Identification & Mitigation.
• Innovation and Improvement Initiatives and Projects.

Qualifications and Skills Required:

• Diploma or degree in Microbiology, Biochemistry, Biotechnology or related subject.
• 3 years’ experience in a pharmaceutical QC laboratory or routine microbiology laboratory or equivalent.
• Supervisory experience in pharmaceutical quality control or similar position would be an advantage.
• Quality and regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
• Experience in having faced successfully local quality audits would be an advantage

Other requirements

• May require some occasional off shift and/or weekend coverage to accommodate schedules and/or project timelines

All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the
pursuit of excellence, diversity and redress.