QA Officer

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description When you’re part of Thermo Fisher Scientific, you’ll do challenging work with a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. The company has a broad range employee benefits scheme that you can tailor to your preference.

Summary: This role is available within QA Operations at Thermo Fisher Scientific, Swindon. The qualified individual will lead the site Product Quality Review (PQR) process and will be responsible for the timely planning, execution, authoring, coordination and completion of PQRs for commercial products. The role will manage the overall PQR lifecycle, including maintenance of the annual review schedule, collection and verification of source data, evaluation and trending of quality and manufacturing information, preparation of PQR reports, coordination of cross-functional review and approval, and tracking of resulting actions to closure. The role will work closely with QA Operations, Operations, Quality Control, MSAT, Engineering, Validation, Regulatory and other relevant functions to ensure PQRs are complete, accurate, scientifically sound and compliant with site procedures and applicable GMP requirements. MSAT will retain ownership of Continued Process Verification (CPV), with this role coordinating closely with MSAT to ensure relevant CPV outputs, trends and conclusions are appropriately incorporated into the PQR process. In addition to PQR responsibilities, the individual will act as a Deviation Investigator within QA Operations, leading and supporting Quality investigations associated with deviations and other quality events. This will include gathering and evaluating relevant information, performing structured root cause analysis, assessing product and quality impact, identifying appropriate corrective and preventive actions (CAPAs), and authoring clear, scientifically sound and inspection-ready investigation reports in accordance with site procedures and applicable GMP requirements.

Own and manage the site Product Quality Review process, including the annual PQR schedule, priorities, status tracking and timely completion of reviews. Perform and author Product Quality Reviews for assigned products in accordance with GMP requirements, corporate standards and site procedures. Coordinate the collection, verification and reconciliation of PQR input data from relevant functions, ensuring data are complete, accurate and traceable to approved source systems. Evaluate and trend product and process performance data, including deviations, investigations, CAPAs, changes, complaints, OOS/OOT results, stability data, manufacturing performance and other relevant quality indicators. Use appropriate data analysis and statistical tools (for example Excel and Minitab) to identify recurring trends, adverse signals and opportunities for improvement. Facilitate cross-functional PQR review meetings, document conclusions and recommendations, and ensure actions arising from PQRs are assigned, tracked and progressed to closure. Develop, maintain and report PQR quality metrics and dashboards, including PQR completion and schedule adherence, overdue inputs and actions, recurring deviations, complaints, OOS/OOT results, CAPA trends and other relevant product quality indicators. Escalate