Perform shop floor QA activities, including line clearance, in-process checks, area clearance, and process verification. Review Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), logbooks, and analytical reports for completeness and compliance. Monitor manufacturing, warehouse, and utility areas to ensure adherence to cGMP, Good Documentation Practices (GDP), and data integrity requirements. Review and approve controlled documents such as SOPs, specifications, protocols, formats, and reports. Participate in investigations related to deviations, incidents, Out-of-Specification (OOS), Out-of-Trend (OOT), market complaints, and implementation of CAPAs. Support change control management, risk assessments, and quality management system (QMS) activities. Coordinate qualification and validation activities, including equipment qualification, process validation, cleaning validation, and computerized system validation. Ensure timely review and closure of deviations, CAPAs, change controls, and audit observations. Monitor environmental and utility qualification records as applicable. Support Annual Product Quality Review (APQR/PQR) preparation and trending activities. Participate in self-inspections, internal audits, customer audits, and regulatory inspections. Ensure training compliance and provide guidance to cross-functional teams on quality and compliance requirements. Maintain audit readiness and ensure adherence to EHS policies and procedures.
