Provide quality oversight for Validation, Engineering, Utilities, HVAC, Process Gases, IT/Computerized Systems (CSV), Warehouse, and Quality Control operations.
Ensure SOPs, Quality Risk Assessment, reports, specification and quality records comply compliance with FDA cGMP, EU GMP, PIC/S GMP, ICH Guidelines, Data Integrity requirements, and company quality standards..
Provide independent quality decisions to ensure product quality, patient safety, data integrity, and regulatory compliance....