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Niche pharma CSV validation skillset and senior (10+ years) reduces candidate pool despite metro location.
Role's pharma regulatory CSV and data integrity requirements limit transferability across industries.
Mandatory 10+ years and specific pharma regulatory validation skills make filters highly strict.
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Own validation activities for computerized systems in clinical/pharma environments ensuring compliance with 21 CFR Part 11, Annex 11, Data Integrity, and Good Documentation Practices.
Lead reviews of SDLC deliverables and test scripts, providing regulatory/validation feedback pre- and post-execution.
Coordinate with project teams through stand ups and follow-ups to resolve issues and ensure timely delivery while managing multi-tasking in a fast-paced setting.
Minimum 10 years of relevant validation experience in clinical/pharma industry.
Experience with manual testing and preferably automated testing using selenium-based tools.
In-depth knowledge of regulatory expectations for computerized systems including 21 CFR Part 11, Annex 11, Data Integrity, and Good Documentation Practices.
Must work UK shift hours and be office-based at least 60% of the time.
Strong background in clinical/pharma validation with deep understanding of regulatory documentation and compliance needs.
Experienced in system development life cycle with ability to critically review and provide feedback on validation deliverables.
Capable of operating effectively in fast-paced environments coordinating between technical and project teams, adhering to strict timelines.