Job Description
Job Purpose
To lead and manage qualification, validation, and requalification activities for equipment, facilities, utilities, and manufacturing processes, ensuring compliance with cGMP, regulatory requirements, and data integrity standards.
Key Responsibilities
- Ensure cGMP, Data Integrity, and regulatory compliance in all qualification and validation activities.
- Prepare, review, implement, and maintain the Validation Master Plan (VMP).
- Plan, execute, monitor, and review qualification/requalification of equipment, instruments, facilities, HVAC systems, water systems, compressed air systems, and utilities.
- Lead facility qualification, utility qualification, and temperature mapping activities.
- Prepare, review, and approve Process Validation, Cleaning Validation, Hold Time Study, and Process Verification protocols and reports.
- Coordinate execution of validation activities, includi...