QC Lead: Microbiology, Environmental Monitoring & Biological Testing

Biovac; Cape Town; On-site; ZAR 500,000 - 800,000; Full time

Job summary

Biovac, a leading sterile vaccine manufacturer in Africa, seeks a dynamic QC Lead for Microbiology, Environmental Monitoring & Biological Testing. The ideal candidate will ensure quality compliance, lead a team, and manage critical laboratory functions within a cGMP facility. With a focus on continuous improvement, this role offers the chance to positively impact vaccine production, driving quality and safety standards.

Qualifications

• Minimum 5 years experience in vaccine / pharmaceutical / biotech manufacturing.
• At least 2-3 years experience at supervisory level.
• Strong knowledge of sterile manufacturing environment.

Responsibilities

• Drive continuous improvement plans and implement quality management.
• Manage approval of laboratory raw data and investigations.
• Oversee environmental monitoring program and data analysis.

Skills

Quality and regulatory compliance

Technical knowledge of aseptic practices

Data Integrity

Environmental Monitoring

Team building and communication

Education

Degree or diploma in Microbiology / Biochemistry / Biotechnology

Job description

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

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.