We are looking for Computer System Validation Specialist with experience in CSV life cycle documents /qualification-related protocols (like URS, FRS, FRA, DS/CS, IQ, OQ, PQ, RTM) for Mumbai Location
Required Candidate Profile
- Understand clients CSV, Quality and Risk management strategy, define and align with the processes and procedures for the program/project
- Assist in providing strategic inputs for CSV projects
- Should have knowledge of GxP system, GAMP, 21 CFR Part11 software validation
- Should be able to gather requirements (user/functional) clearly from multiple stakeholders
- Able to prepare CSV life cycle documents /qualification-related protocols (like URS, FRS, FRA, DS/CS, IQ, OQ, PQ, RTM)
- Support in preparing test scripts annexures
- Able to execute/ support in executing test scripts and recording results
- Should understand serialization concepts in the pharmaceutical industry (SAP Advanced Track & Trace for Pharmaceuticals)
- Able to handle the projects independently