- Computer System Validation (CSV) activities as per GAMP-5 and 21 CFR Part 11
- Preparation and execution of URS, FS, DS, IQ, OQ, PQ documents
- Validation of PLC, SCADA, DCS, MES and LIMS systems
- Risk assessment, impact analysis and change control documentation
- Review and management of validation lifecycle documents
- Coordination with Engineering, QA and IT teams during validation activities
Key Requirements:
- Minimum 2+ years of hands-on CSV experience
- Solid knowledge of regulatory guidelines and compliance
- Excellent English communication skills (documentation and discussion)
- Immediate joiner preferred (buyout option available)
- Pharma or regulated industry experience will be an added advantage