Qc Lead: Microbiology, Environmental Monitoring

**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 Lead: Microbiology, Environmental Monitoring & Biological Testing to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Degree or diploma in Microbiology / Biochemistry/Biotechnology or equivalent - Recognition is given to Prior Learning and practical experience. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - At least 5 years experience in vaccine / pharmaceutical / biotech manufacturing industry. - At least 2-3 years experience at supervisory level. - Experience in quality and regulatory compliance within a cGMP facility. - Technical knowledge of aseptic practices and Microbiological/Biological methods. - Strong knowledge of sterile manufacturing environment. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: - Drive 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. - Manage approval of laboratory raw data and investigation of out of specification results where applicable (Micro & Biological). - Manage the compilation of analytical method validation/ verification/ transfer protocols and reports. - Manage the compilation review, approval of user requirement specification and/or user briefs, qualification documents, CAPEX approval. - Risk Assessment, Change Management, and implementation of new and updated equipment and software. - Manage the selection and procurement of analytical test equipment and participation in equipment qualification, (Micro & Biological). - Manage Sampling and testing and release of starting materials (e.g., raw materials, production devices and packaging materials) used in production processes. - Manage Micro & Biological testing of intermediate and finished product testing as per product specifications. - Manage the review of analytical method validation/ verification protocols and reports and co-ordination with focus on Micro & Biological testing. - Manage the Stability Program, including compiling stability protocols and reports, related to the Micro & Biological testing. - Manage the writing and updating of material and product test methods and standard operating procedures. - Manage Data Integrity in the QC Laboratory with reference to Micro & Biological along with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when available. - Participate in quality audits and closing any gaps of findings. - Ensure that OOS and OOT investigations are initiated and completed to the correct standard within the required due dates. - Participate in inspections, investigations, risk management and quality review exercises. - Manage project activities according to agreed project timelines and within cGMP requirements. - Manage the Operational Expense (OPEX), and Capital expenditure (CAPEX), cost control, and budgeting for the Micro & Biological department in conjunction with the Head of QC. - Manage the Environmental monitoring program, for site and ensure that it meets cGMP requirements. - Manage Environmental Monitoring data analysis and reports are provided to stakeholders. - Provide specialist support for GMP cell banks and work with Science & Innovation (S&I) team to transfer cell bank knowledge into the Microbiology/Biochemistry department. - Experience working closely with production, QA and regulatory affairs. - Proven experience Planning, prioritizing and tracking of QC activities to ensure OTIF delivery. - Metrics driven in all aspects of job that ensures performance of team. (Delivery, Quality, Safety, Finance, People) - Highly motivated individuals that is passionate about all aspects relating to QC. - Strong team building and communication skills. **Application Deadline: 25 July 2025** **_Disclaimer:_