Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at site
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
