Head Sterile Quality Compliance

1 day ago

himachal pradesh, 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 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

  • Head Sterile Quality Compliance

    1 week ago

    himachal pradesh, 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

    3 days ago

    himachal pradesh, 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

    1 week ago

    himachal pradesh, 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...

  • Head Sterile Quality Compliance

    7 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...

  • Manager – Sterile Micro

    7 days ago

    Nalagarh, Himachal Pradesh, India, Himachal Pradesh 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- Sterility Assurance

    10 hours ago

    himachal pradesh, India Panacea Biotec Full time

    Job Responsibilities:Oversight of compliance with respect to Sterility Assurance to ensure alignment to the Site, Global and Regulatory requirements, including but not limited to: Aseptic Practices, Environmental Monitoring, Cleaning & Sanitization, Sterilization, Media Simulation, Change Over Controls, Clean Utilities, Gowning & Personnel Flow.Assure...

  • Manager- Sterility Assurance

    2 weeks ago

    Baddi, Himachal Pradesh, India, Himachal Pradesh Panacea Biotec Full time

    Job Responsibilities:Oversight of compliance with respect to Sterility Assurance to ensure alignment to the Site, Global and Regulatory requirements, including but not limited to: Aseptic Practices, Environmental Monitoring, Cleaning & Sanitization, Sterilization, Media Simulation, Change Over Controls, Clean Utilities, Gowning & Personnel Flow.Assure...

  • Assistant Officer

    2 days ago

    Himachal Pradesh, India Mankind Pharma Full time

    Date: 21 Oct 2024- Location: Poanta, HP, IN- Facility: 5238**Company Details**: MANKIND PHARMA LTD, KISHANPURA ,JAMNIWALA RAOD ,PAONTA SAHIB, SIRMOUR ,H.P **Job Title**: ASST.OFFICER - To do sampling of daily water samples, sterile water for Injection, raw materials and maintain related documents. - To do sampling related activities and maintain related...

  • Manager - Production-sterile

    3 weeks ago

    Dewas, Madhya Pradesh, India Sun Pharmaceutical Industries Full time

    Job Title Manager - 1 Production-Sterile Business Unit Sun Global Operations Job Grade G10 Location Dewas SGO At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine ...

  • Associate Quality Assurance

    1 week ago

    Visakhapatnam, Andhra Pradesh, India Pfizer Full time

    Preferred Education/ Qualification B. Pharm/M. Pharm/M.Sc. Experience: 4- 6 years of experience in Quality Assurance / MQA of sterile dosage manufacturing facility. Core Competencies: - Technology Transfer - Change Management process - Risk assessments principles and tools - Validation of manufacturing equipment’s - Drug Product Process validations -...