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    Job · 16902428

    Amneal Pharmaceuticals logo

    Executive, QC Environment Monitoring

    Amneal Pharmaceuticals · Mehsana · onsite · Posted 42d ago

    Undisclosed5–8 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Description:
    This role is responsible for conducting environmental monitoring activities and quality analyses in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates environmental monitoring data in terms of accuracy and precision against predetermined specifications to ensure facility and product integrity. The position identifies ongoing quality issues related to environmental conditions and takes proactive measures to prevent potential contamination or production problems. It applies various measuring devices, testing equipment, and prescribed methodologies to assess environmental monitoring results based on defined quality criteria. The role audits and monitors environmental conditions and quality control processes against both internal and regulatory standards to uphold compliance. It tests environmental samples from manufacturing areas to verify conformance with quality specifications and regulatory expectations. The position reports environmental monitoring deviations and out-of-specification results to the appropriate quality and production stakeholders. It supports the organizations commitment to maintaining a controlled manufacturing environment for the production of safe and compliant pharmaceutical products.

    Essential Functions:
    • Perform environmental monitoring sampling and quality analyses in manufacturing areas in accordance with established specifications and regulatory requirements.
    • Interpret and evaluate environmental monitoring data for accuracy and precision against predetermined quality and regulatory standards.
    • Identify ongoing quality issues related to environmental conditions and implement preventive measures to avoid potential contamination events.
    • Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to assess environmental monitoring results.
    • Audit and monitor environmental conditions and quality control processes against defined internal and regulatory standards.
    • Test environmental samples from manufacturing areas to verify compliance with quality specifications and contamination control requirements.
    • Report environmental monitoring deviations and out-of-specification results to relevant stakeholders in a timely manner.
    • Contribute to process improvement initiatives by identifying opportunities to enhance environmental monitoring programs and methodologies.
    • Maintain accurate and complete documentation of all environmental monitoring activities in compliance with GMP and GLP requirements.


    Additional Responsibilities:
    Education:
    • B. Pharm B. Pharm - Required
    • M. Pharm M. Pharm - Preferred
    Experience:
    • 5 years or more in 5 - 8 Years
    Specialized Knowledge: Licenses:


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    auditsSamplingProcess ImprovementPharmaceutical ManufacturingQuality ControlManufacturingcomplianceQCPharmaceutical

    About Amneal Pharmaceuticals

    Amneal Pharmaceuticals logo

    Amneal Pharmaceuticals

    Pharma

    5.5k+

    employees

    2002

    24 years old

    Bridgewater, New Jersey

    United States (USA)

    About

    Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.

    Industries

    PharmaBiotechnologyClinical Research

    Employee ratings

    1,455 reviews

    4.2/ 5

    Culture

    4.0

    Career growth

    3.5

    Work-life

    4.2

    Employees rate it well for

    Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65

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