Head Sterile Quality Compliance

4 hours ago

Nalagarh Himachal Pradesh India, Himachal Pradesh 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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    1 week ago

    Nalagarh, 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...

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    Nalagarh, India Immacule Lifesciences Full time

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