Quality Control Lead: Chemistry & Material Handling (Pharma)

• 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 of analytical method and cleaning 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, (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.
• Participation in project teams as a QC representative.
• Ensure that Chemistry testing is performed according to the Company Stability Program. Assist with the compilation of stability protocols and reports.
• Manage the transfer of analytical methods from technology transfer partners to the comapny 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 (e.g., Pfizer and Sanofi) 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.

ABC Worldwide