Qc Lead Micro

2 weeks ago

Cape Town, South Africa Biovac Full time

**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 Micro & Biological Testing to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree or diploma in Microbiology / Biochemistry/Biotechnology or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 5 years of experience in the sterile vaccine/pharmaceutical/biotech manufacturing industry
- At least 2-3 years of experience at the 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
- Experience in having faced successful local and/or international quality audits.

**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 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 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 the execution of project activities according to agreed project timelines.
- 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 visual inspection activities of in-process and final products as per the required SOPs and product specifications related to vaccines and packaging activities.
- Manage the review of analytical method validation/ verification protocols and reports and coordination with a focus on Micro & Biological testing.
- Maintaining that Stability Program, including compiling stability protocols and reports, related to Micro & Biological testing.
- Participation in project teams as a QC representative.
- Ensure that Micro & Biological testing is performed according to the Biovac Stability Program. Assist with the compilation of stability protocols and reports.
- Manage the transfer of analytical methods from technology transfer partners to Biovac and their implementation in the laboratory, with a focus on 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.
- Liaise with suppliers on technical issues where applicable.
- Manage training, coaching, and competency assessment of Micro & Biological staff to approve procedures and protocols.
- Participate in quality audits and close any gaps in 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.
- Execute project activities according to agreed project timelines and within cGMP requirements.
- Manage the Operational Expense (OPEX), Capital expenditure (CAPEX), cost control, and budgeting for the Micro & Biological department in conjunction with the QC Manager.
- Participate in significant Micro & Biological investigations that can impact product Quality and patient safety.
- Lead significant Micro & Biological Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
- Lead engagement with external third-party stakeholders (e.g., Pfizer and Sanofi) regarding Micro & Biological areas.
- Provide technical guidance to QC teams and to other stakeholders within the business from a Micro & Biological perspective.
- Manage the review and approval of significant documentation within the Micro & Biological team as defined within local procedures.
- Manage the Environmental monitoring program, for the 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.
- Review and approve significant documentation w

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