Senior Executive – In-Process Quality Assurance

Job Summary The Senior Executive – Cell & Gene Therapy (CGT) Manufacturing is responsible for executing and monitoring CGT production activities in compliance with cGMP/cGTP requirements. The role ensures aseptic process adherence, real-time documentation, deviation reporting, and shopfloor regulatory compliance. Key Responsibilities • Execute CGT manufacturing processes as per approved SOPs and batch records. • Perform line clearance and equipment readiness checks prior to batch initiation. • Ensure strict adherence to aseptic handling and sterile practices. • Maintain chain-of-custody traceability throughout the manufacturing lifecycle. • Complete real-time Batch Manufacturing Record (BMR) documentation accurately. • Ensure shopfloor compliance with cGMP and cGTP standards. • Identify, document, and report deviations as per QMS requirements. • Review batch records and manufacturing documents for accuracy and completeness. Mandatory Qualifications & Skills • Strong knowledge of cGMP / cGTP guidelines • Hands-on experience in Cell & Gene Therapy manufacturing • Sound understanding of QMS, GDP, and Data Integrity principles • Experience in aseptic operations • Good communication and coordination skills • Ability to work effectively in regulated shopfloor environments Preferred / Good to Have • Exposure to Process Validation and Cleaning Validation • Experience in APQR preparation • Knowledge of Environmental Monitoring & Contamination Control • Experience in documentation preparation and review