Perform and monitor Quality Assurance activities in pharmaceutical manufacturing operations. Conduct line clearance and routine shop-floor QA inspections. Review and verify BMR/BPR, batch records, logbooks and other manufacturing documents. Ensure compliance with GMP, GDP and approved SOPs. Monitor manufacturing processes and ensure adherence to approved procedures. Handle and investigate deviations, non-conformances and quality incidents. Initiate, review and monitor CAPA activities. Handle and monitor Change Control activities. Coordinate with Production, QC, Warehouse and Engineering teams for quality-related issues. Review and update SOPs, protocols, reports and quality documents. Support OOS/OOT investigations in coordination with QC, wherever applicable. Participate in internal, customer and regulatory audits. Ensure proper implementation of Good Documentation Practices (GDP). Conduct self-inspections and audit readiness activities. Monitor quality system compliance and ensure timely closure of observations. Maintain QA records, reports and documentation as per regulatory requirements.Sourced from naukri
