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    Job · 16885277

    Amneal Pharmaceuticals logo

    Assistant Manager, QC Investigation

    Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago

    Undisclosed10–12 yrsfulltimeSourced fromNaukri

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

    About this role

    Description:
    The position is responsible for in-process and final product quality investigations in compliance with internal standards and global regulatory requirements. The role focuses on interpreting analytical and microbiological data for accuracy and precision against approved specifications.The role involves identifying recurring quality issues, investigating OOS, OOT, deviations, and trends, and preventing potential production and product quality risks. The role audits and monitors manufacturing outputs using validated methods, instruments, and predefined specifications to accept or reject materials and finished goods. The role ensures robust documentation, regulatory readiness, and continuous improvement, while supporting corrective and preventive actions to enhance overall quality performance.

    Essential Functions:
    • Perform detailed QC investigations for OOS, OOT, deviations, and atypical results
    • Interpret and evaluate in-process, finished product, and stability data against specifications
    • Review analytical data, audit trails, and laboratory documentation for data integrity
    • Identify ongoing and potential quality issues and recommend preventive measures
    • Execute root cause analysis and ensure timely CAPA implementation
    • Audit and monitor QC outputs for compliance
    • Support acceptance or rejection decisions for RM, PM, IP, and FG samples
    • Ensure regulatory compliance with GMP, GLP, and pharmacopoeial requirements
    • Trend quality data to detect systemic risks and process variability
    • Support internal and external audits and inspections


    Education:
    • B. Pharm B. Pharm - Required
    • M. Pharm M. Pharm - Preferred
    Experience:
    • 10 years or more in 10 - 12 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

    Product qualityauditsCAPARoot Cause AnalysisRegulatory ComplianceManufacturingcomplianceQC

    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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