Aseptic Manufacturing

3 days ago

India Biocon Biologics Full time

Biocon Biologics is a fully integrated 'pure play' biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe. 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.

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