CSV Engineer
- Hiring Organisation
- Resolian
- Location
- Fordham, Cambridgeshire, UK
- Employment Type
- Full-time
Responsibilities Validate computerized systems in accordance with 21 CFR Part 11, EU Annex 11, OECD 17, and GAMP 5. Support CSV activities of the Quality Management System including deviations, CAPAs, and change controls related to GxP computerized systems. Review and create validation documentation - such as risk assessments, user requirements functional … years' direct validation experience within regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, EU Annex 11, and GAMP 5 requirements. Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles. Must be able to stay current with industry trends, regulatory changes, and best ...