Executive - QA (IPQA - DP)

Position: Executive – DPQA Department: Quality Assurance (QA) Experience: 2 to 5 Years Qualification: <M.Sc>. / M.Pharm Key Responsibilities 1. Drug Product (DP) Quality Assurance Activities Perform line clearance activities in warehouse, washing, solution preparation, filtration, filling, visual inspection, and packing areas. Conduct In-Process Quality Assurance (IPQA) checks during manufacturing and packaging operations. Ensure contemporaneous documentation practices in compliance with data integrity requirements. Perform audit trail review and user management activities in computerized systems. Review logbooks, GMP documents, and operational records for completeness and compliance. Carry out sampling activities at various stages of manufacturing and packing processes as per approved procedures. Perform Acceptable Quality Level (AQL) inspections for finished products. Review executed Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated documentation. 2. IPQA Activities – Fill Finish Operations Perform line clearance activities in fill-finish grade areas, including manufacturing, filtration, filling, sealing, and packaging operations. Execute and document in-process quality checks on the fill-finish shop floor. Monitor manufacturing and filtration activities to ensure compliance with approved procedures and cGMP requirements. Conduct routine IPQA checks in fill-finish operations and follow up on corrective actions for observed deficiencies. Perform continuous monitoring of aseptic operations in Grade B manufacturing and filling areas. Review logbooks, batch records, environmental monitoring records, and other GMP documents related to shop floor activities. Ensure adherence to approved SOPs, batch records, and quality standards during operations. 3. Documentation & Compliance Review GMP documents, logbooks, protocols, and records for compliance with regulatory requirements. Ensure accurate and timely completion of documentation activities. Verify compliance with Good Documentation Practices (GDP) and Data Integrity principles. Support document control activities and archival of quality records. Assist in the review and closure of observations identified during routine QA activities. 4. Validation and Qualification Support Participate in Media Fill activities and ensure proper execution and documentation. Track and update Media Fill schedules and records. Support gowning qualification activities and associated documentation. Participate in qualification and validation activities from a QA perspective. Ensure compliance during validation and qualification studies. 5. Quality Systems & Continuous Improvement Identify and escalate quality and compliance issues observed during shop floor monitoring. Support implementation of corrective and preventive actions (CAPA) arising from QA observations. Participate in internal audits, self-inspections, and regulatory audit preparations. Contribute to continuous improvement initiatives related to product quality, compliance, and operational excellence. Required Skills & Competencies Good knowledge of cGMP, GDP, and Data Integrity requirements. Understanding of aseptic manufacturing and fill-finish operations. Experience in IPQA activities, line clearance, in-process checks, and shop floor monitoring. Knowledge of batch record review and GMP documentation practices. Familiarity with audit trail review and computerized system compliance. Understanding of media fill, gowning qualification, and contamination control practices. Strong attention to detail and documentation skills. Good communication and coordination abilities.