Description

Essential Functions:
- Lead and supervise aseptic injectable manufacturing operations on the shopfloor
- Ensure strict compliance with cGMP (current Valuable 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
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred

Experience:
- 15 years or more in 15+ Years

📌 Senior Manager, Manufacturing Injectables (Ahmedabad)
🏢 Amneal
📍 Ahmedabad