Job
Description
Lead Quality Assurance operations, ensuring compliance with GxP and continuous improvement. Oversee Quality Systems to maintain compliance with regulatory requirements and procedures. Ensure timely execution of Quality Assurance activities, including Change Controls, CAPA, Deviations, OOS, OOT, and Market Complaints. Represent QA during regulatory/customer audits, track compliance plans, and implement corrective actions. Monitor the effectiveness of CAPA programs and ensure accurate implementation. Facilitate batch review and release per regulatory requirements. Investigate and resolve non-conformances, ensuring appropriate corrective and preventive actions. Ensure execution of Annual Product Reviews and escalate recommendations to senior management. Maintain adherence to safety, data integrity, and ethical conduct policies. Oversee in-process Quality Assurance (IPQA) for compliance with shop floor activities. Review and approve key documents across Production, Warehouse, Quality Control, Engineering, R&D, and EHS. Participate in cross-functional meetings, ensuring alignment on quality, compliance, and process improvements. Support sterility assurance programs, media fills, and aseptic process monitoring. Coordinate internal audits and ensure timely resolution of observations. Monitor and enhance aseptic practices in the manufacturing environment. Ensure timely investigation and resolution of customer and market complaints. Provide batch disposition decisions and approve release documentation. Ensure timely submission of required documents to regulatory and cross-functional teams. Prepare and review protocols, procedures, and QMS elements to sustain compliance. Identify training needs for QA team members and conduct required training programs. Lead quality discussions in periodic review meetings, supporting compliance and process improvements. Track and monitor timely closure of deviations, root cause investigations, and CAPA. Ensure timely resolution of queries from customers and third-party review teams. Promote continuous quality improvements through effective cross-functional collaboration. Promptly report and escalate non-conformances or critical quality issues for assessment.
