Manager, MES & PI Systems
HyderabadFull-timeMid levelPosted over a month ago
Mid-level legal role at Amgen in Hyderabad.
About the role
Ancillary support to internal and external audits, inspections, and data integrity assessments.
What you'll do
- Serve as System Owner for Manufacturing Execution System (MES) and PIHistorian, ensuring reliability, data integrity, and continuous GMP compliance
- Execute configuration and system changes under formal change control to optimize performance while maintaining validated state
- Ensure system documentation, configuration records, and validation deliverables remain inspection-ready at all times
- Maintain alignment with global computer systems validation (CSV) and Annex 11 / 21 CFR Part 11 requirements
What you need
- Compliance
- GMP
- Documentation