QC Lead Chemistry & Material Handling
ABC Worldwide
- Cape Town, Western Cape
- Permanent
- Full-time
- Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry /Biotechnology or equivalent.
- At least 8 years of experience in the vaccine/pharmaceutical/biotech manufacturing industry.
- At least 5 years of experience at the management level.
- Experience in quality and regulatory compliance within a cGMP facility.
- Technical knowledge of Good Laboratory Practices and Chemistry methods.
Core Technical Delivery:
- 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 Chemistry and site.
- Manage approval of laboratory raw data and investigation of out-of-specification results where applicable (Chemistry and Material Handling)
- 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, (Chemistry).
- 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 Chemistry 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 Chemistry testing.
- Maintaining that Stability Program, including compiling stability protocols and reports, related to Chemistry testing
- Ensure that Chemistry testing is performed according to the Company’s Stability Program. Assist with the compilation of stability protocols and reports.
- Manage the transfer of analytical methods from technology transfer partners to the company and their implementation in the laboratory, with a focus on chemistry 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 Chemistry 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 Chemistry 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 Expenses (OPEX), Capital expenditure (CAPEX), cost control, and budgeting for the Chemistry department in conjunction with the QC Manager.
- Participate in significant Chemistry investigations that can impact product Quality and patient safety.
- Lead significant chemistry Risk assessments following cGMP guidelines (e.g., ICH Q9, ICG Q10, etc).
- Lead engagement with external third-party stakeholders regarding Chemistry areas.
- Provide technical guidance to QC teams and other stakeholders within the business from a Chemistry perspective.
- Manage the review and approval of significant documentation within the Chemistry team as defined within local procedures.