Sterile Quality Compliance LeadImmacule Lifesciences • Nālāgarh, Republic Of India, IN
Sterile Quality Compliance Lead
Immacule Lifesciences • Nālāgarh, Republic Of India, IN
30+ days ago
Job descriptionResponsible 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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Compliance Lead • Nālāgarh, Republic Of India, IN
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