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.
Position 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.
Responsibilities:
- 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 adverse trends, emerging risks, systemic issues and overdue actions through the appropriate QA Operations, product governance and site leadership forums.
- Support preparation for and participation in client and regulatory audits/inspections relating to Product Quality Reviews and associated product quality trends, including retrieval and presentation of supporting data, rationale, actions and evidence of effective PQR governance.
- Act as process owner for the site PQR process, including ownership of the PQR SOP, templates, annual schedule and governance model; provide training and guidance to contributors and reviewers; and drive continuous improvement of the process, tools and ways of working.
- Coordinate closely with MSAT, which owns Continued Process Verification (CPV), to align PQR activities with ongoing product and process monitoring. Ensure relevant CPV outputs, statistical trends, signals and conclusions are considered within PQRs, and communicate PQR findings back to MSAT where further monitoring, assessment or improvement activity may be warranted.
- Prepare concise PQR outputs, quality trend summaries, key risks and recommended actions for Management Review, product governance and other relevant leadership forums, supporting informed product lifecycle decisions and continuous improvement.
- Support product quality risk management by identifying adverse trends and potential systemic issues arising from PQRs, ensuring they are appropriately assessed, escalated and progressed through the relevant quality system or governance process.
- Act as a Deviation Investigator within QA Operations, leading and supporting Quality investigations for deviations and other quality events. Perform structured root cause analysis, assess product and quality impact, identify appropriate corrective and preventive actions (CAPAs), and author clear, scientifically sound and inspection-ready investigation reports in accordance with site procedures and applicable GMP requirements.
EH&S:
Understand and ensure implementation of emergency procedures and safe systems of work. Ensure compliance with environment, health and safety rules, signage and instructions at all times. Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.
Minimum Requirements/Qualifications:
- Science-based degree, e.g. BSc or equivalent relevant experience.
- Minimum of 3 years of professional experience in a GMP pharmaceutical manufacturing, quality, technical or validation environment; experience with Product Quality Reviews/Annual Product Reviews is preferred.
- Strong understanding of Product Quality Review principles, pharmaceutical quality systems and product/process lifecycle management.
- Competence in data analysis and trending using tools such as Excel and/or Minitab; ability to interpret complex quality and manufacturing data and draw clear conclusions.
- Solid understanding of applicable EU/UK and US GMP regulations and guidance relevant to Product Quality Reviews and pharmaceutical quality systems.
- Strong technical writing skills, with experience preparing clear, concise and inspection-ready reports, investigations, deviations, CAPAs and/or SOPs.
- Excellent interpersonal, facilitation, communication and organisational skills, with the ability to coordinate inputs and decisions across multiple functions.
- Ability to manage multiple reviews and competing deadlines while maintaining attention to detail and data quality.
What’s in it for you:
Competitive base salary, Annual bonus, Free on-site car parking, Contributory Pension, Private medical insurance and Flexible benefits.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
