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 (Positive 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 (India)
🏢 Amneal
📍 India