Job Summary
The role is responsible for ensuring that site production systems and equipment, utilities, facilities, laboratory instruments/systems, Data & Tracking systems and User Defined Attributes consistently and reproducibly meet predefined specifications, while maintaining the overall validation status and data integrity requirements in line with GMP and regulatory expectations. The position leads validation strategy and execution, computerized system validation, and the Site Data Integrity Program in close collaboration with cross-functional teams.
Key Responsibilities
Develop, review, and ensure adherence to the Site Validation Master Plan (SVMP) for production processes, systems/equipment, utilities, facilities, laboratory instruments/systems, testing methods, Data & Tracking systems and User Defined Attributes, ensuring timely action closure and status reporting.
Ensure timely development, review, approval, archival, retri...
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