Posted:2 weeks ago|
Platform:
Work from Office
Full Time
1. Responsible for review of User Requirement Specification, Design Qualification, FAT Protocols, SAT Protocols, Installation Qualification, Operational Qualification, Performance Qualification Protocols and reports.
2. Responsible for preparation of commissioning protocols, FAT, SAT and associated risk and GAP analysis documents.
3. Responsible for preparation of facility, equipment, area qualification protocols, reports and execution.
4. Accountable for ensuring the compliance the qualification activities in -line with global quality/regulatory requirements.
5. Responsible for Engineering compliance and review of Engineering department SOPs, PMP calibration and facility maintenance schedules.
6. Responsible for review of facility and equipment drawings.
7. Responsible for monitoring and review of computerized system validation (CSV).
8. Responsible for monitoring and review of risk assessment, incidents and change controls related to qualification and engineering, IT and other cross functional departments (wherever required).
9. Responsible for training coordination and QMS activities.
10. Accountable for equipments/facility qualification life cycle documents storage and archival.
11. Responsible for the cleaning, process validation protocols preparation, review and execution of activities.
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