Description:

The role is responsible for end-to-end leadership, supervision, and control of injectable manufacturing operations while ensuring strict adherence to cGMP (current Good Manufacturing Practices). 

Essential Functions:

• Lead and supervise aseptic injectable manufacturing operations on the shopfloor (Vial  Line)
• Ensure strict compliance with cGMP (current Good Manufacturing Practices) and GMP & Regulatory Compliance (Good Manufacturing Practices and Regulatory Compliance)
• Oversee Compounding & Reconstitution and Filling, stoppering and sealing activities
• Ensure adherence to Aseptic Techniques and Asceptic Practices and Behaviour
• Manage CIP & SIP (Cleaning In Place & Sterilization In Place) and Sterilization & Depyrogenation processes
• Oversee Environmental Monitoring and Non-Viable & Viable Particle monitoring
• Ensure execution and review of BMR (Batch Manufacturing Record) and BPR (Batch Packing Record)
• Drive Change Control & Deviation Management and support Investigation Analysis
• Ensure Cross-contamination Prevention and Safety & Hygiene Practices
• Support Equipment and Process Validation and Autoclave Operation and Validation
• Build team capability through Training and Competency Management Responsible for Manpower Optimization and production optimization
• Maintain audit readiness for internal and external regulatory inspections

Additional Responsibilities:

• Responsible to give training to all the subordinates, technicians, and operators of the department.
• Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
• Responsible to attend the training as per training schedule and to ensure training as per TNI.

Qualifications