QC Lead: Chemistry & Material Handling 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 Lead: Chemistry & Material Handling to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry or equivalent.
• Recognition is given to Prior Learning and practical experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 6 years' experience in vaccine / pharmaceutical / biotech manufacturing industry.
• At least 3 years' experience at management level.
• Experience in quality and regulatory compliance within a cGMP facility.
• Strong leadership and team management abilities.
• Experience with LIMS, chromatography data systems and /or electronic documentation systems.
• Proficient in method and data review.
• Proven troubleshooting and problem-solving abilities within analytical testing.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Drive continuous improvement plans and priorities through the implementations of appropriate tools or methodologies to proactively manage risk, reduce wastage and to improve quality on site.
• Management of all Materials (Raw Material and Packaging) testing and Chemistry testing activities for product release.
• Participation in project teams as QC representative.
• Assist with the transfer of analytical methods from technology transfer partners to Biovac and their implementation in the laboratory.
• Assist with compiling of analytical method validation / verification protocols and reports.
• Assist with selection of analytical test equipment and participation in equipment qualification e.g., review of qualification documents.
• Assist with writing and updating of material and product specifications and test methods and standard operating procedures.
• Liaison with suppliers on technical issues where applicable.
• Maintaining laboratory operations at cGMP standards to ensure quality, safety and regulatory compliance.
• Departmental Management of the QC laboratory budget, ensuring alignment with GMP and regulatory requirements.
• Forecast costs for analytical testing, stability studies, reference standards, and consumables.
• Control expenditure related to equipment calibration, maintenance, and outsourced testing.
• Collaborate with procurement to optimize vendor contracts for reagents, instruments, and lab services.
• Prepare CAPEX proposals for new analytical technologies and lab upgrades.
• Monitor budget performance, analyze variances, and implement corrective actions.
• Maintaining that Stability Program, including compiling stability protocols and reports.
• Ensure that relevant testing is performed according to the Biovac Stability Program.
• Assist with the compilation of stability protocols and reports.
• Participation in quality audits and closing any gaps of findings.
• Ensure that OOS and OOT investigations are initiated and completed to the correct standard.
• Identify and / or participate in inspections, investigations, risk management and quality review exercises.
• Chemistry testing to support aseptic vaccine manufacturing performed to required quality and regulatory standards and within agreed time frames.
• Chemistry assay qualifications, validations, and verifications.
• Undisrupted, punctual, and safe operation of staff and processes pertaining to Chemistry Testing and the institutes operations.
• Technology transfer activities involving Chemistry testing within the agreed time frames.
• Review specifications, test methods and other QC procedures.
• Ensure the qualification and maintenance of premises and equipment used by the Chemistry team.
• Ensure that the required initial and continuing training of his teams personnel is carried out and adapted according to need.
• Responsible to ensure that the Material Handling (Raw Material and Packaging Materials) sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
• Approve or reject starting materials, packaging materials intermediate bulk and finished product.
• Co-ordinate sampling and testing of sampling materials, packaging materials, components, production devices, intermediate, bulk and finished products as week as all warehouse related activities.