Production Operator

Emcure Pharmaceuticals Limited; Sanand; On-site; INR 400,000 - 700,000; Full time

Job summary

Emcure Pharmaceuticals Limited in Sanand, Ahmedabad (Gujarat) is seeking professionals with 1 to 8 years of experience for roles in aseptic filling and injectable manufacturing. The position covers aseptic filling, batch manufacturing and complex sterile operations.

The candidate should have Diploma/B.Sc./ITI in a relevant discipline and exposure to regulatory pharma environments, with a focus on GDP and cleanroom discipline.

Qualifications

• Diploma/BSc/ITI in a relevant technical discipline.
• Experience in a regulatory-approved pharmaceutical injectable manufacturing plant is mandatory.

Responsibilities

• Operate aseptic filling machines, capping machines, vial washing machines and related equipment.
• Carry out line clearance, machine setup, changeover and operation per approved SOPs.
• Perform filtration, product filling and capping while maintaining aseptic conditions.
• Ensure compliance with cGMP, data integrity and regulatory requirements.
• Execute dispensing, compounding, solution preparation and bulk manufacturing activities.
• Record process parameters accurately in Batch Manufacturing Records (BMRs).
• Follow approved production schedules and ensure timely batch completion.
• Operate autoclaves and terminal sterilization equipment and handle sterilization cycles.

Skills

Aseptic filling

cGMP knowledge

Documentation

Shift work

Education

Diploma/BSc/ITI

Job description

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
• 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.
• 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
• Oncology injectables
• 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.
• 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