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: Biological Testing to join a goal-oriented team.
QUALIFICATIONS NEEDED:
- Degree or diploma in Immunology / Biotechnology / Biochemistry or equivalent.
- Recognition is given to Prior Learning and practical experience.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- At least 4 years experience in sterile vaccine / pharmaceutical / biotech manufacturing industry with QC Laboratory.
- At least 1 year experience at supervisor level.
- Experience in quality and regulatory compliance within a cGMP facility.
- Experience in aseptic (sterile) manufacturing is preferred.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- 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.
- Planning and assisting with routine laboratory testing.
- Co-ordinating testing of Stability analytical verification and/or analytical validation samples related to Biological testing and associated activities.
- Compiling data trends data analysis and associated reports related to Biological testing to the correct standard and on time.
- Reviewing of laboratory raw data and logbooks including OOS/MDDs and or OOT results from internal and/or external testing related to Biological testing.
- Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard.
- Training and upskilling of analysts within Biological Testing.
- Training analysts on theoretical aspects of Biological testing with hands-on training approach by means of demonstration and supervision using test methods SOPs and other documentation and formal assessments.
- Performing formal competency assessments of performance (e.g. Endotoxin etc.)
- Selecting analytical test equipment for procurement and participating in equipment qualification e.g. review of qualification documents from a Biological perspective.
- Assisting in writing and updating of material and product specifications and test methods and standard operating procedures related to Biological testing.
- Participating 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 inspections investigations risk management and quality review exercises.
- Participating in Biological testing related to technology transfers from other vaccine manufacturers and other project activities.
- 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 Biological testing with new and upcoming technologies (e.g. LIMS new hardware and software programs new technologies) when necessary.
- Co-ordinating Biological 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 Biological testing.
Application Deadline: 14 October 2025
If you do not receive a response from us within three weeks of submitting your application please understand that your application was not successful.
Disclaimer:
Dear Applicant we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying you acknowledge and consent to the collection use and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns our Human Capital department is available to provide clarification. We look forward to reviewing your application.