QA Validation & Qualification Documentation Reviewer

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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:

• Validation Master Plans or local validation plans
• User Requirement Specifications
• Risk assessments
• Design Qualification Installation Qualification Operational Qualification and Performance Qualification protocols and reports
• Process Performance Qualification and process validation protocols and reports
• Cleaning validation documentation
• Aseptic Process Simulation / Media Fill documentation
• Computerized system validation packages
• QC Chemistry and Microbiology qualification or requalification documents
• Equipment utilities facilities and engineering qualification documentation
• 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:

• 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.