Manager – Sterile Micro / EM Compliance

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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