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