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 Valuable 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.
- Good 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