Senior Executive

A. Quality Assurance Operations Monitor manufacturing and packaging activities to ensure compliance with approved SOPs, BMRs, BPRs, and GMP requirements. Perform in-process QA checks and line clearance before starting manufacturing and packaging operations. Review Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for completeness, accuracy, and compliance. Ensure proper implementation of approved procedures, specifications, and quality standards. Coordinate with Production, Quality Control (QC), Warehouse, Engineering, and other departments. B. Documentation and Compliance Prepare, review, revise, and control SOPs, formats, protocols, and other quality documents. Ensure good documentation practices (GDP) and data integrity. Maintain and review logbooks, equipment records, cleaning records, and other GMP documents. Support internal audits, external audits, customer audits, and regulatory inspections. C. Deviation, CAPA, and Change Control Initiate, investigate, and document deviations, incidents, and non-conformances. Perform root cause analysis and coordinate corrective and preventive actions (CAPA). Manage change control activities and assess their impact on product quality and validated systems. Follow up on CAPA implementation and verify effectiveness within approved timelines. D. Validation and Qualification Support process validation, cleaning validation, and equipment qualification activities. Review and execute validation protocols and reports as assigned. Ensure periodic review and maintenance of validated status in coordination with relevant departments. E. Quality Systems and Continuous Improvement Support handling of market complaints, product recalls, and quality investigations. Monitor compliance with current GMP requirements and applicable regulatory guidelines. Participate in risk assessments, quality reviews, and continuous improvement initiatives. Ensure timely closure of assigned quality-system activities. 3. Required Knowledge and Skills Good knowledge of Schedule M, applicable GMP requirements, and relevant regulatory guidelines. Knowledge of SOP management, deviation, CAPA, change control, and risk assessment. Experience in BMR/BPR review, line clearance, and shop-floor QA activities. Understanding of data integrity principles, including ALCOA+. Good communication, analytical, documentation, and problem-solving skills. Proficiency in MS Office and pharmaceutical documentation systems. 4. Key Performance Indicators (KPIs) Timely review and closure of batch documentation. Compliance with GMP and approved SOPs. Timely closure of deviations, CAPAs, and change controls. Reduction in documentation errors and repeat deviations. Audit observations and compliance performance. Timely completion of assigned quality-system activities.