Prepare, review, execute, and approve validation protocols and reports including process validation (PVP/PVR), cleaning validation, packing validation, and bulk hold time studies while handling qualification activities such as DQ, SAT, IQ, OQ, and PQ
Review, assess, and approve Quality Management System (QMS) elements including change controls, planned and unplanned deviations, and ensure timely closure with proper investigation and CAPA
Ensure compliance with regulatory requirements (GMP, ICH), customer expectations, and internal quality standards
Conduct training programs on QMS and regulatory guidelines for cross-functional teams
Monitor, analyze, and trend quality data to identify gaps and implement continuous improvement initiatives
Review and approve quality-related documents such as protocols, reports, calibration certificates, vendor/service provider documents, and trend reports
