Ensure compliance with GMP, GDP, GLP and regulatory requirements across the plant.
Handle regulatory & customers audits and ensure timely closure of CAPA.
Implement and monitor Quality Management System (QMS) including deviations, change control, OOS, CAPA, etc.
Review and approve SOPs, batch records, protocols, and quality documents.
Ensure proper documentation practices and data integrity.
Oversee product release/rejection and approval of RM/PM/FG COAs.
Manage Quality Control operations, including testing, stability, and lab compliance.