UK) Position Summary The QA Specialist will support the Quality Assurance department in maintaining compliance of computerised systems and electronic Quality Management Systems (eQMS). This includes contributing to
validation activities in alignment with GAMP 5, Annex 11, and other relevant regulations. The role requires an understanding of Computer System
Validation (CSV) principles and practical involvement in regulated environments. Essential … department including but not limited to, document control, supplier qualification, technical agreements, quality records, and internal/external audit programme. To have a good working knowledge of Computer System
Validation and its practical implementation at MedPharm. Provide QA input into the creation of quality records, including change controls, deviations, out-of-specification (OOS) results, CAPAs, facilities and equipment documentation, audit … Vendors Travel requirements : None Education and Experience Bachelor's or Masters' degree in Life Sciences, Engineering, Computer Science, or related discipline desirable but not essential. Training in Computer System
Validation or GAMP 5 preferred. Computer System
Validation training desirable. Knowledge, Skills, and Abilities Proven experience working with ETQ, MasterControl, or similar eQMS platforms - configuration, administration, and user training. Strong working
More ❯
