Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
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 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:
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Validation Master Plans or local validation plans
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User Requirement Specifications
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Risk assessments
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Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports
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Process Performance Qualification and process validation protocols and reports
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Cleaning validation documentation
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Aseptic Process Simulation / Media Fill documentation
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Computerized system validation packages
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QC Chemistry and Microbiology qualification or requalification documents
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Equipment, utilities, facilities, and engineering qualification documentation
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Requalification, revalidation, and lifecycle review documents
To verify that assigned documents include clear scope, predefined acceptance criteria, traceability to user and GMP requirements, defined responsibilities, appropriate data integrity controls, documented deviation handling, and conclusions supported by objective evidence.
To confirm that validation and qualification documentation is aligned with approved procedures, protocols, change controls, deviations, investigations, CAPA records, and other relevant GMP documentation.
To support QA review of computerized system validation documentation, including intended use, risk assessment, user access controls, data integrity controls, backup and restore considerations, change control, and testing evidence.
To assess basic data integrity expectations within validation and qualification packages, including traceability of raw data, completeness of supporting evidence, consistency of results, and alignment between protocols, deviations, reports, and final conclusions.
To review qualification and validation deviations, failed acceptance criteria, discrepancies, and protocol variations to confirm that investigations, impact assessments, CAPA requirements, and final conclusions are complete before document approval or closure.
To review change controls for potential impact on qualified or validated status and identify whether requalification, revalidation, regression testing, or continued verification may be required, escalating complex decisions where appropriate.
To support periodic or lifecycle review of qualified equipment, utilities, systems, and validated processes by reviewing assigned documentation and identifying gaps, overdue actions, or evidence requiring escalation.
To raise clear, objective, and timely comments on documentation deficiencies and support cross-functional teams in resolving review observations.
To support QA review and approval workflows within applicable document management or quality systems, in line with training, procedures, and assigned QA approval authority.
To collaborate with CQV, MSAT, Engineering, QC, Operations, and QA colleagues to support timely completion of validation and qualification documentation.
To contribute to the maintenance and improvement of document review checklists, templates, and ways of working.
To maintain awareness of applicable GMP requirements, internal procedures, and site expectations related to validation, qualification, computerized systems, documentation, data integrity, deviation/CAPA, and change control.
To escalate unresolved GMP risks, data integrity concerns, unjustified deviations, inadequate validation evidence, or potential product quality impact to senior QA, QA management, and the Qualified Person where applicable.
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:
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Science based degree e.g. BSc or MSc
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Some experience in validation document review within the pharmaceutical industry, preferably in sterile manufacturing.
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Proficient knowledge of process validation, cleaning validation and continuous process improvement.
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Knowledge of mainstream statistical software analysis programs such as MiniTab.
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Solid understanding of EU/US GMP regulations and guidelines for UK as per the ‘Orange Guide.’
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Technical writing skills - Deviations, reports, investigations, SOPs.
- Excellent interpersonal skills, communication, and organizational skills
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Ability to multi-task, meeting tight deadlines.
