Qc Lead: Chemistry
1 week ago
**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. **Application Deadline: 14 October 2025** **_Disclaimer:_
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Qc Supervisor: Chemistry
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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 QC Supervisor: Chemistry to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Diploma or degree in Analytical Chemistry, Chemistry or equivalent. -...
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