Designation: Operator
- Injectable Production Job

Location:
Sanand, Ahmedabad (Gujarat)

Experience:
1 to 8 Years Qualification:
• Diploma/ B.
Sc./ ITI (relevant technical discipline)
• Experience in a regulatory-approved pharmaceutical injectable manufacturing plant is mandatory. Areas of Exposure:
• Aseptic Filling Operations
• Batch Manufacturing
• Terminal Sterilization
• Complex Injectable Manufacturing
• Vial, Ampoule, Cartridge, PFS (Prefilled Syringe) operations
• Isolator based filling systems

Key Responsibilities
Filling Area
• Operate and monitor aseptic filling machines, capping machines, vial washing machines, depyrogenation tunnels, and related equipment.
• Perform line clearance, machine setup, changeover, and operation activities as per approved SOPs.
• Carry out filtration, product filling, and capping activities while maintaining aseptic conditions.
• Ensure compliance with cGMP, data integrity, and regulatory requirements. Batch Manufacturing
• Execute dispensing, compounding, solution preparation, and bulk manufacturing activities.
• Operate manufacturing equipment such as mixing vessels, reactors, homogenizers, and filtration systems.
• Record process parameters accurately in Batch Manufacturing Records (BMRs).
• Follow approved production schedules and ensure timely completion of batches. Terminal Sterilization
• Operate autoclaves and terminal sterilization equipment.
• Perform loading and unloading of sterilization cycles as per validated procedures.




• Monitor critical process parameters and complete all relevant documentation.
• Ensure compliance with sterilization validation and regulatory requirements. Complex Injectable Operations
• Handle manufacturing and filling activities related to complex products such as:
• Liposomal formulations
• Suspensions
• Emulsions
• Depot injections
• Oncology injectables
• High-potent products
• Follow containment and safety procedures during product handling. Documentation & Compliance
• Complete BMRs, logbooks, equipment records, and production documents accurately.
• Follow Good Documentation Practices (GDP).
• Participate in investigations, deviation management, CAPA implementation, and audit readiness activities.
• Maintain compliance with USFDA, MHRA, EU GMP, WHO-GMP, and other regulatory requirements. Safety & Housekeeping
• Maintain cleanroom discipline and aseptic behavior.
• Adhere to EHS guidelines and safety requirements.
• Perform routine cleaning and sanitization activities in production areas.
• Support 5S and continuous improvement initiatives. Desired Skills
• Sound knowledge of cGMP and aseptic manufacturing practices.
• Understanding of cleanroom behavior and contamination control.
• Ability to work in shifts.
• Valuable documentation and equipment handling skills.
• Exposure to regulatory inspections and audit requirements will be an added advantage. Preferred Industry
• USFDA-approved Injectable Manufacturing Plants
• EU GMP / MHRA-regulated Injectable Facilities
• Sterile Pharmaceutical Manufacturing Units

📌 Production Operator (Sanand)
🏢 Emcure Pharmaceuticals
📍 Sanand