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Aseptic Manufacturing

Aseptic Manufacturing

Biocon Biologicsajit, India
23 hours ago
Job description

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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    Manufacturing • ajit, India