Quality Assurance Executive

Job Description

Key Responsibilities: Documentation & Record-Keeping: Maintain and review SOPs, BMRs, BPRs, change control documents, and other QA-related documents. Ensure Good Documentation Practices (GDP) are followed. Compliance & Audits: Conduct internal quality audits and prepare CAPA reports. Assist in regulatory and customer audits (USFDA, MHRA, WHO, etc.). Ensure compliance with cGMP, GLP, and other regulatory requirements. Deviation, CAPA, & Change Control: Investigate deviations and OOS (Out of Specification) incidents. Initiate and monitor Corrective and Preventive Actions (CAPA). Manage change control documentation and impact assessment. Batch Release & Review: Review completed batch records and analytical data before batch release. Participate in decision-making for batch disposition. Training & Awareness: Conduct or coordinate GMP training for production and quality teams. Maintain training records and assess training effectiveness. Validation & Qualification: Support in process validation, cleaning validation, and equipment qualification activities. Review validation protocols and reports. Continuous Improvement: Participate in Quality Risk Management (QRM) initiatives. Suggest improvements to enhance product quality and process efficiency. Job Type: Full-time Pay: ₹15,000.00 - ₹22,000.00 per month Benefits: Provident Fund Schedule: Day shift Work Location: In person