To perform QA review of assigned qualification and validation lifecycle documents, including:
1. Validation Master Plans or local validation plans
2. User Requirement Specifications
3. Risk assessments
4. Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols and reports
5. Process Performance Qualification and process validation protocols and reports
6. Cleaning validation documentation
7. Aseptic Process Simulation / Media Fill documentation
8. Computerized system validation packages
9. QC Chemistry and Microbiology qualification or requalification documents
10. Equipment, utilities, facilities, and engineering qualification documentation
11. 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:
12. Science based degree BSc or MSc
13. Some experience in validation document review within the pharmaceutical industry, preferably in sterile manufacturing.
14. Proficient knowledge of process validation, cleaning validation and continuous process improvement.
15. Knowledge of mainstream statistical software analysis programs such as MiniTab.
16. Solid understanding of EU/US GMP regulations and guidelines for UK as per the ‘Orange Guide.’
17. Technical writing skills - Deviations, reports, investigations, SOPs.
18. Excellent interpersonal skills, communication, and organizational skills
19. Ability to multi-task, meeting tight deadlines.