QC Lead Chemistry & Material Handling

• 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.

• 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.

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