Position Summary
This role is available within the QA Operations department at Thermo Fisher Scientific, Swindon. The QA Validation & Qualification Documentation Reviewer supports the QA review of qualification and validation documentation across defined GMP validation activities. The role focuses on ensuring that assigned documents are complete, accurate, traceable, and aligned with approved procedures, protocols, acceptance criteria, change controls, and GMP documentation expectations.
The role includes review of documentation generated by Commissioning & Qualification, Requalification, MSAT, Quality Control, Engineering, Operations, and other relevant site teams. Documentation may include equipment qualification, utilities and facilities qualification, computerized system validation, process validation, cleaning validation, aseptic process simulation, requalification, revalidation, and lifecycle review records.
The individual will identify documentation gaps,...