Senior Computer System Validation Specialist
- Location
- United Kingdom
risk-based principles aligned with GAMP 5, CSA, data integrity, e-record/e-signature, and applicable GxP expectations, Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions, Ensure validation strategies are proportionate to system … risk, intended use, business process impact, patient/subject safety, product quality, data integrity, and regulatory impact. CSV/CSA Deliverables : Author, review, or approve validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/design/configuration specifications, IQ/OQ/ ...