Head Sterile Quality Compliance

3 days 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 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

  • 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 periodicallyEnsure the microbial monitoring program in the site is...

  • 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...

  • Manager – Sterile Micro

    2 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

    1 week 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...

  • Machine Operator- Vial Filling

    1 week ago

    himachal pradesh, India Panacea Biotec Full time

    Responsibilities:Cleaning & Operation of Vial Filling & Sealing Machine / PFS Filling Machine.Sterile area cleaning, equipment cleaning and recording of temperature & relative humidity of area.Assist in machine setting, assembling/disassembling, format change over and maintenance of Vial Filling machine and PFS Filling Machine.Cleaning, Wrapping and storage...

  • 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 ...

  • Quality Head

    4 weeks ago

    Bhopal, Madhya Pradesh, India Jobted IN C2 Full time

    Key Responsibilities Quality Control Assurance Develop implement and monitor quality standards procedures and systems across the rice production line Ensure regular inspection and testing of raw materials paddy in-process grains and finished rice products Oversee grading processes including head rice percentage broken rice levels moisture...

  • Associate Quality Assurance

    4 days 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 -...

  • regulatory and compliance liaison expert- vaccine

    1 week ago

    Himachal Pradesh, India Panacea Biotec Full time ₹ 5,00,000 - ₹ 25,00,000 per year

    Job Title: Regulatory & Compliance Liaison (RCL) - VDSP, Lalru & VDPP, BaddiReports To: COO – VaccineDepartment: COO – VaccineLocation: Baddi, Himachal PradeshRole Summary:The Regulatory & Compliance Liaison (RCL) will support the COO- Vaccine in maintaining the plant's global and domestic compliance status. This role is key to ensure operational...

  • Quality Head- Seating Systems

    3 days ago

    madhya pradesh, India SV Management Consultants Full time

    Role: Quality Head - Responsible for developing, implementing, and managing quality control systems and strategies to ensure the highest Quality standards in the manufacturing & assembly of automotive seating systems. Responsibilities Process Excellence & Quality Control: Conceptualize and lead the quality management strategy aligned with business...