Key Responsibilities

- Execute manufacturing and aseptic fill-finish activities as per the approved production schedule and Batch Manufacturing Record (BMR).
- Perform and monitor vial washing, depyrogenation tunnel, aseptic vial filling, stoppering, capping, and lyophilization (freeze drying) operations.
- Operate, set up, clean, and troubleshoot fill-finish equipment and associated utilities.
- Ensure aseptic techniques are followed throughout manufacturing operations.
- Conduct line clearance before and after production activities.
- Perform equipment assembly, disassembly, cleaning, sterilization, and preparation for production.
- Monitor critical process parameters during filling and lyophilization cycles and document observations accurately.
- Prepare, filter, sterilize, and transfer product solutions as per approved procedures.
- Support media fill activities, aseptic process simulations, and process validations.
- Participate in equipment qualification (IQ/OQ/PQ), process validation,



and technology transfer activities.
- Ensure compliance with cGMP, GDP, SOPs, ALCOA+ data integrity principles, and EHS requirements.
- Complete Batch Manufacturing Records (BMR), equipment logbooks, and other production documentation accurately and in a timely manner.
- Identify, document, and support investigations for deviations, non-conformances, CAPA, and change controls.
- Coordinate with Quality Assurance, Quality Control, Engineering, Validation, Warehouse, and Maintenance teams to ensure smooth production.
- Maintain Grade A/B/C/D cleanroom standards and comply with gowning and contamination control procedures.
- Ensure proper environmental monitoring coordination during aseptic operations.
- Maintain housekeeping and implement 5S practices within the production area.
- Support regulatory inspections and internal/external audits.

📌 Filling Machine Operator (Jadcherla)
🏢 Hetero Biopharma
📍 Jadcherla