Posted:8 hours ago|
Platform:
Work from Office
Full Time
- 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
- 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
Immacule Life Sciences
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