Head Sterile Quality Compliance

2 days ago

Nalagarh, India Immacule Lifesciences Full time

Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at siteConduct sterile quality management review periodicallyPeriodic review and routine check of classified areas like manufacturing, Microbiology and utility areasPreparation & adherence to Sterility Assurance Calendar consisting of Review timelines, training calendar and requalificationEnsuring 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 productOversee the media fill programOversee the microbial OOS and OOT investigations, ensure microbial excursions are adequately handled and investigatedEnsure microbial trend data is analyzed and actions are taken proactively.Environmental Monitoring (EM)Personnel MonitoringMedia Fill Simulations (Process Simulations)Change controls related to Facility/ Process/ Utilities which may impact the current validated state with a focus on SterilityEnsuring periodic training of personnel involved in Sterility process and ensure practices to be followed while ensuring desired behavior on shop floorEnsure the microbial testing at the laboratory meets the appropriate guidance and pharmacopeiaEnsure the microbial data generated in laboratory is used meaningfully for plant operationsOversight of aseptic interventions, gowning qualifications, and contamination control strategiesEnsure appropriate Data Integrity controls are applied and followed

  • Head Sterile Quality Compliance

    2 days ago

    Nalagarh, India Immacule Lifesciences Full time

    - Responsible 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...

  • Head Sterile Quality Compliance

    16 hours ago

    Nalagarh, India Immacule Lifesciences Full time

    Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at siteConduct sterile quality management review periodicallyPeriodic review and routine check of classified areas like manufacturing, Microbiology and utility areasPreparation & adherence to Sterility Assurance...

  • Head Sterile Quality Compliance

    12 hours ago

    Nalagarh, India Immacule Lifesciences Full time

    Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at siteConduct sterile quality management review periodicallyPeriodic review and routine check of classified areas like manufacturing, Microbiology and utility areasPreparation & adherence to Sterility Assurance...

  • Head Sterile Quality Compliance

    1 hour ago

    Nalagarh, India Immacule Lifesciences Full time

    Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at siteConduct sterile quality management review periodicallyPeriodic review and routine check of classified areas like manufacturing, Microbiology and utility areasPreparation & adherence to Sterility Assurance...

  • Manager – Sterile Micro

    16 hours ago

    Nalagarh, India Immacule Lifesciences 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-...

  • Manager – Sterile Micro

    2 days ago

    Nalagarh, India Immacule Lifesciences 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 periodicallyEnsure the microbial monitoring program in the site is...

  • Manager – Sterile Micro

    12 hours ago

    Nalagarh, India Immacule Lifesciences 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 periodicallyEnsure the microbial monitoring program in the site is...

  • Manager – Sterile Micro

    3 hours ago

    Nalagarh, India Immacule Lifesciences 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 periodicallyEnsure the microbial monitoring program in the site is...

  • Manager – Sterile Micro

    2 days ago

    Nalagarh, India Immacule Lifesciences 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 -...

  • Head Sterile Quality Compliance

    2 days ago

    Nalagarh, Himachal Pradesh, India, Himachal Pradesh Immacule Lifesciences Full time

    Responsible for driving excellence in sterility assurance practices, meeting the global regulatory requirements, drive sterility Assurance Program at siteConduct sterile quality management review periodicallyPeriodic review and routine check of classified areas like manufacturing, Microbiology and utility areasPreparation & adherence to Sterility Assurance...