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A world-leading pharmaceutical organisation is seeking a QA Administrator /Document Controller to help oversee the critical administration of GxP Documentation, Record Management, and Training activities. Based in Harwell, Oxfordshire, this role is essential in ensuring processes align with regulatory expectations and business needs.
Job Responsibility
Manage the full lifecycle of GxP documents and records, including creation, issuance, maintenance of controlled document listings, reconciliation, and logbook administration
Administer paper-based and electronic document workflows, chain of custody, and manage the archival of cGMP records both on-site and off-site
Ensure strict adherence to Good Documentation Practices (GDP) and Data Integrity requirements across all documentation and records
Support the site's GxP Training program by issuing requirements based on role profiles, tracking completion, and providing training as needed
Provide essential documentation and record management support during internal and external audits and inspections
Collaborate with cross-functional teams on continuous improvements to document control lifecycles and workflows (including eDMS optimisation)
Requirements
Experience in the pharmaceutical sector
Strong practical knowledge and emphasis on current Good Manufacturing Practices (cGMP)
Demonstrated ability or aptitude to quickly acquire a strong understanding of GxP regulations