Manager - Quality (DDRC) - QMS

Job Description

This role supports Quality Management System (QMS) activities including tracking and reviewing CRFs, CAPAs, deviations, and SOPs across multiple sites Responsibilities include documentation control, data analysis, digital transition support, and coordination with site teams to ensure compliance with cGMP standards The position also involves audit support, workflow optimization, and cross-functional collaboration to drive timely closure of quality events B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Track and follow up on pending TrackWise CRFs and CAPAs. Perform effectiveness checks for closed CAPAs and CRFs. Generate and maintain statistics on quality documents (e.g., deviation closures, CRFs, RAs, CAPAs). Monitor and track SOP periodic reviews across sites. Support SOP updates, including formatting checks and revision history verification. Facilitate the creation and routing of CRFs for SOP revisions. Assist in the transition from physical to electronic forms (Leucine project). Support the review of manufacturing documentation (e.g., shipping/receiving logs, PM records). Collaborate on defining and improving document workflows and review processes. Prepare and review OOS, OOT, and lab incident investigations; initiate change controls as needed. Review planned and unplanned deviations for accuracy, completeness, and cGMP/data integrity compliance. Collaborate with site teams to resolve gaps identified during QMS event review and documentation. Engage with customers and site teams to ensure timely closure of critical QMS events. Coordinate site review activities and ensure workflow efficiency. Route documents through the ENSUR application or other platforms across Piramal plants. Participate in customer audits and regulatory inspections, supporting site teams as needed. Lead or contribute to additional assignments as directed by the Head of Department (HOD).