Head Sterile Quality Compliance

2 weeks ago

New Delhi, India Immacule Lifesciences Full time

- Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site
- Conduct sterile quality management review periodically
- Periodic review and routine check of classified areas like manufacturing, Microbiology and utility areas
- Preparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalification
- Ensuring SOP adherence to clean room facility / utilities/ equipment / Personnel qualifications whichever has a potential to impact the Sterility of the product.
- Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product
- Oversee the media fill program
- Oversee the microbial OOS and OOT investigations, ensure microbial excursions are adequately handled and investigated
- Ensure microbial trend data is analyzed and actions are taken proactively.
- Environmental Monitoring (EM)
- Personnel Monitoring
- Media Fill Simulations (Process Simulations)
- Change controls related to Facility/ Process/ Utilities which may impact the current validated state with a focus on Sterility
- Ensuring periodic training of personnel involved in Sterility process and ensure practices to be followed while ensuring desired behavior on shop floor
- Ensure the microbial testing at the laboratory meets the appropriate guidance and pharmacopeia
- Ensure the microbial data generated in laboratory is used meaningfully for plant operations
- Oversight of aseptic interventions, gowning qualifications, and contamination control strategies
- Ensure appropriate Data Integrity controls are applied and followed

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