Ernst & Young
RC-REGULATORY COMPLIANCE-CSV - MES -Manager
- Auditing
- Compliance
... understanding of GAMP 5 , 21 CFR Part 11, EU Annex 11, Annex 15, data integrity, ICH Q9/Q10, and relevant regional guidance. - Strong Expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans. Familiarity with CSA principles and risk‑based testing. - Experience working ...
Bangalore, भारत