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, provide clear review comments, support timely resolution with cross-functional teams, and escalate complex technical, regulatory, scientific, or data integrity concerns to senior QA colleagues, subject matter experts, QA management, or the Qualified Person where applicable. This Band 5 role provides QA documentation review and assigned approval support while developing broader validation, qualification, and GMP regulatory judgement.

Responsibilities

• To perform QA review of assigned qualification and validation lifecycle documents, including Validation Master Plans, URS, Risk Assessments, and IQ/OQ/PQ protocols.
• To verify that assigned documents include clear scope, predefined acceptance criteria, traceability to user and GMP requirements, and appropriate data integrity controls.
• To confirm that validation and qualification documentation is aligned with approved procedures, protocols, change controls, deviations, and CAPA records.
• To support QA review of computerized system validation documentation, including intended use, risk assessment, and user access controls.
• To assess basic data integrity expectations within validation and qualification packages, including traceability of raw data and completeness of supporting evidence.
• To review qualification and validation deviations, failed acceptance criteria, and discrepancies to confirm that investigations and impact assessments are complete.
• To review change controls for potential impact on qualified or validated status and identify whether requalification or revalidation may be required.
• To support periodic or lifecycle review of qualified equipment, utilities, systems, and validated processes.
• To raise clear, objective, and timely comments on documentation deficiencies and support cross-functional teams in resolving observations.
• To collaborate with CQV, MSAT, Engineering, QC, Operations, and QA colleagues to support timely completion of documentation.
• To maintain awareness of applicable GMP requirements, internal procedures, and site expectations.
• To escalate unresolved GMP risks, data integrity concerns, or potential product quality impact to senior QA management.

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 MSc.
• Some experience in validation document review within the pharmaceutical industry, preferably in sterile manufacturing.
• Proficient knowledge of process validation, cleaning validation and continuous process improvement.
• Knowledge of mainstream statistical software analysis programs such as MiniTab.
• Solid understanding of EU/US GMP regulations and guidelines for UK as per the ‘Orange Guide.’
• Technical writing skills - Deviations, reports, investigations, SOPs.
• Excellent interpersonal skills, communication, and organizational skills.
• Ability to multi-task, meeting tight deadlines.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.