Key Responsibilities Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements. Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents. Manage OOS/OOT, deviations, CAPA, change controls, complaints, recalls and investigations. Ensure effective implementation of IPQA, data integrity, quality risk management, self-inspections and audit compliance. Approve/review batch release, raw materials, packaging materials, intermediates and finished products. Ensure timely execution of process/cleaning/equipment validation, calibration, preventive maintenance and stability studies. Lead regulatory, customer and GMP audits, including inspection readiness and timely closure of observations. Review and approve Quality/Technical Agreements and monitor contract manufacturers, suppliers and external laboratories. Ensure compliance with pharmacopoeial, regulatory and ...