QC Supervisor Microbiology and Environmental Monitoring at Biovac

• 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 QC Supervisor: Microbiology and Environmental Monitoring to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or diploma in Microbiology / Biotechnology / Biochemistry or equivalent

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3 years experience in vaccine / pharmaceutical / biotech manufacturing industry within the QC Laboratory,
• Experience in leading a team, planning and troubleshooting.
• Experience in quality and regulatory compliance within a cGMP facility

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Driving continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk, reduce wastage and to improve quality on site.
• Co-ordinating all the testing and activities associated to ensure that the Environmental Monitoring Program is executed as per procedures for starting materials intermediate, bulk, and final products.
• Executing the Environmental Monitoring (EM) Program for assessing the manufacturing environment and utilities and escalating associated issues.
• Testing of Sterility samples, Stability testing, and analytical verification and/or analytical validation samples related to Microbiology testing & Environmental Monitoring.
• Identifying organisms related to Microbiology testing & Environmental Monitoring, and support the associated investigation, when necessary.
• Inspecting of Aseptic Process Simulations (APS) samples and associated activities.
• Compiling data trends, data analysis and associated reports for EM program to the correct standard and on time.
• Reviewing of laboratory raw data, including OOS/MDDs and or OOT results from internal and/or external testing related to Microbiology & Environmental Monitoring testing.
• Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard.
• Training and upskilling of analysts within Microbiology Testing with hands-on training approach for analysts in theoretical aspects of Microbiology, and techniques by means of demonstration and supervision, using test methods, SOPs, and other documentation.
• Performing formal competency assessments of performance, (e.g., Sterility testing, etc.).
• Participate in the selection and procurement of analytical test equipment and participation in equipment qualification (e.g., review of qualification documents).
• Adhering to Pharmaceutical Quality System (PQS) requirements (e.g., SOPs, CAPAs, Deviations, Risk Assessments, and Change Controls).
• Participating in quality audits and close out gaps and findings.
• Participating in Microbiological & EM testing related to technology transfers from other vaccine manufacturers and other project activities.
• Participating in inspections, investigations, risk management and quality review exercises.
• Ensuring that DMS queries are attended to and resolved within a reasonable time as the System Owner.
• Co-ordinating Data Integrity in the QC Laboratory with reference to Microbiological & Environmental Monitoring testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
• Co-ordinating Microbiological & EM Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
• Assisting with implementation of the site Containment and Control Strategy (CSS), with reference to Microbiology & Environmental Monitoring.

Application Deadline: 21 November 2025