Lead and manage site-wide QMS activities, including deviations, CAPA, change control, risk management, investigations, complaints, and annual product quality reviews (APQR/PQR). Ensure implementation, maintenance, and continuous improvement of QMS processes in compliance with cGMP requirements. Establish and monitor QMS performance metrics and drive closure of quality system records within defined timelines. Review, approve, and ensure timely closure of deviations, OOS, OOT, incidents, and market complaints. Facilitate robust root cause analysis using tools such as 5 Why, Fishbone Diagram, and FMEA. Monitor CAPA effectiveness and identify recurring trends to implement preventive actions. Oversee the change control process, ensuring appropriate impact assessments and regulatory compliance. Lead quality risk management activities using ICH Q9 principles. Ensure timely implementation and effectiveness verification of approved changes.
