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Microbiology Compliance Manager

Microbiology Compliance Manager

Immacule LifesciencesNālāgarh, Republic Of India, IN
24 days ago
Job description
  • Ensure and assist the Head Sterile Quality Compliance for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at the microbiology laboratory.
  • Participate in the sterile quality management review periodically
  • Ensure the microbial monitoring program in the site is adequate
  • Environmental Monitoring (EM)
  • Personnel Monitoring
  • Media Fill Simulations (Process Simulations)
  • Periodic review and routine check of classified areas in microbiology lab areas
  • Review validation / protocol studies which has potential to directly or indirectly impact the sterility of the product
  • Participate in the media fill program and provide meaningful insights from a microbiology perspective
  • 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.
  • Review 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 microbial testing and environment monitoring
  • Oversight of aseptic interventions, gowning qualifications, and contamination control strategies
  • Ensure appropriate Data Integrity controls are applied and followed
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    Compliance Manager • Nālāgarh, Republic Of India, IN

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