The Parenteral/Steile Manufacturing Operator is responsible for carrying out aseptic manufacturing operations related to the production of sterile pharmaceutical products, including injectables, ophthalmics, biologics, or other sterile dosage forms. The role involves operating production equipment, maintaining cGMP compliance, adhering to aseptic practices, and ensuring product quality and operational efficiency.

Key Responsibilities

Production Operations
- Perform sterile manufacturing activities according to approved Batch Manufacturing Records (BMRs) and SOPs.
- Operate and monitor equipment used in sterile production processes such as:
- Washing Machines
- Sterilizers/Autoclaves
- Dry Heat Sterilizers (Depyrogenation Tunnel)
- Formulation Vessels
- Filling Machines
- Stoppering and Capping Machines
- Vial and Ampoule Processing Equipment
- Execute product changeovers and line clearance activities.

Aseptic Operations
- Work in Grade A, B, C, and D cleanroom environments.
- Follow gowning and aseptic procedures to prevent contamination.




- Participate in aseptic filling and sterile manufacturing activities.
- Ensure compliance with contamination control and cleanroom requirements.

Equipment Operation & Cleaning
- Perform equipment setup, operation, basic troubleshooting, cleaning, and sanitization.
- Carry out routine cleaning and maintenance activities as per SOPs.
- Report equipment abnormalities and assist engineering teams during maintenance.

Documentation
- Complete batch records, equipment logs, and production documentation accurately.
- Maintain compliance with Positive Documentation Practices (GDP).
- Report deviations and unusual observations promptly.

GMP & Compliance
- Comply with cGMP, EHS, Data Integrity, and regulatory requirements.
- Follow all quality and safety procedures during manufacturing operations.
- Support internal audits and regulatory inspections.

Material Handling
- Dispense and transfer materials as per approved procedures.
- Verify

📌 Sterile Processing Technician (Guwahati)
🏢 SUN PHARMA
📍 Guwahati