Lead and maintain the site Quality Management System in compliance with cGMP, ICH, WHO, USFDA, EU GMP, and other applicable regulatory requirements. Review and approve SOPs, specifications, protocols, reports, and quality documents. Ensure effective implementation of change control, deviation management, CAPA, risk assessment, and annual product quality review. Provide QA oversight for API manufacturing operations. Ensure compliance with Batch Manufacturing Records (BMR), Batch Packaging Records (where applicable), and Positive Documentation Practices (GDP). Review and approve batch records and support batch disposition/release. Monitor critical manufacturing processes and ensure adherence to validated procedures.