Execute CSV activities as per GAMP 5, 21 CFR Part 11, and EU Annex 11 Prepare and execute validation deliverables...: o Validation Plan / VMP sections o URS, FS, DS o Risk Assessments (FMEA / Risk-based) o IQ, OQ, PQ protocols and reports...
in process design and documentation. Support Computer System Validation (CSV) activities and ensure compliance with 21 CFR Part... in production planning, shop floor operations, and inventory management specific to pharma, but does not require SAP experience...
portfolio updates). Legacy Systems: Ability to reverse engineer data models and workflows from legacy tools and map them... requirements for GxP (auditability, security, performance). Compliance/CSV: Familiarity with GxP, 21 CFR Part 11/Annex 11, risk...
Consulting - Enterprise Risk (ER) - Regulatory Compliance -Senior - CSV As part of our EY-ER- Regulatory Compliance team... and lead internal initiatives. The opportunity We are seeking a highly experienced and detail-oriented Senior CSV...