Key Responsibilities

• Support implementation and maintenance of QMS processes in Production.
• Handle documentation related to deviations, CAPA, change controls, and investigations.
• Ensure timely closure of quality incidents and track action items.
• Review production-related GMP documentation for completeness and compliance.
• Coordinate with QA, Production, Engineering, and Warehouse teams for QMS activities.
• Maintain and update QMS trackers, logs, and databases.
• Support internal audits, regulatory inspections, and compliance reviews.
• Ensure adherence to data integrity principles (ALCOA+).
• Assist in root cause analysis (RCA) and implementation of corrective and preventive actions.
• Monitor compliance of SOPs and ensure timely updates/revisions.
• Prepare periodic QMS reports and KPI summaries for management review.