Aseptic Manufacturing

Biocon Biologics

Position: - Aseptic Manufacturing

Experience:- 12 to 14 Years of Experiences

Key Responsibilities

1. Compliance & Documentation

• Follow current Good Manufacturing Practices (cGMP) and ensure all activities are documented online and in real-time.
• Ensure Good Documentation Practices (GDP) are followed for all records, logbooks, and checklists.
• Adhere to entry and exit procedures for aseptic and controlled areas as per SOP.
• Update status boards and maintain accurate online entries in BMRs and logs.

2. Environmental Monitoring & Equipment Handling

• Monitor and record temperature, differential pressure, UV lamp hours, and LAF readings as per defined frequency.
• Perform fogging, cleaning, and maintenance of aseptic, sealing, and sterile corridor areas.
• Operate, clean, and maintain aseptic area equipment such as vial/cartridge filling machines, sealing machines, lyophilizers, LAFs, pass boxes, and garment cubicles per SOP.
• Coordinate preventive maintenance and calibration of instruments and equipment with maintenance/instrumentation teams.

3. Aseptic Operations

• Follow aseptic practices and behaviors in the sterile area at all times.
• Perform solution filtration, capsule filter integrity testing, and aseptic connections as per SOP.
• Conduct vial/cartridge filling and sealing operations for liquid and lyophilized products.
• Carry out machine assembly, changeover, and troubleshooting during operations.
• Load and unload vials in/from lyophilizer and autoclave as required.

4. Process & Quality Assurance

• Perform filled volume checks and gas purging entries as per BMR/SOP.
• Ensure filled and sealed containers are transferred to the packing area or cold room as applicable.
• Participate in Aseptic Process Simulation (Media Fill) and gowning requalification as per plan.
• Provide personnel monitoring samples (finger dab/gown) to microbiology after operations.
• Carry out non-viable particle count as per defined frequency.
• Execute development batches in coordination with R&D.

5. Safety & Training

• Report any incidents, deviations, or accidents immediately to the supervisor.
• Participate in cGMP, SOP, BMR, protocol, and other required trainings and maintain updated training records.