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 ...