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, including sampling, monitoring, and d...