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    Job · 18741377

    Amneal Pharmaceuticals logo

    Assistant Manager, QA Reviewer

    Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 30d 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 defining and specifying the activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products within a global pharmaceutical environment. The position builds and maintains the infrastructure and systems necessary to consistently ensure the timely delivery of quality-compliant products. It supports the review and evaluation of quality documentation, batch records, and manufacturing outputs against defined internal and regulatory standards. The role ensures efficient and effective workflows, procedures, policies, and review programs are in place and adhered to across manufacturing operations. It manages in-process product quality in coordination with vendors and contract manufacturers. The position facilitates communication with customers and vendors to resolve quality-related issues in a timely and compliant manner. It reports and troubleshoots manufacturing process deviations and defects identified in finished goods. The role contributes to continuous improvement initiatives aimed at reducing defects, errors, and rework across manufacturing operations. It also supports the identification and development of outsourcing vendors and suppliers according to organizational quality standards.

    Essential Functions:
    • Define and specify quality activities, processes, and standards for quality review programs in compliance with regulatory requirements
    • Build and maintain quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products
    • Review and evaluate quality documentation, batch records, and manufacturing outputs against internal and regulatory standards including 21 CFR Part 210 211 and GMP guidelines
    • Ensure efficient workflow, procedures, policies, and review programs are implemented and maintained across manufacturing operations
    • Manage in-process product quality in coordination with vendors and contract manufacturers to meet defined quality specifications
    • Communicate with customers and vendors to investigate and resolve quality review-related issues in a timely manner
    • Report and troubleshoot manufacturing process deviations and defects identified during quality review activities
    • Identify and implement process improvements to reduce costs, defects, errors, and rework in quality review and manufacturing operations
    • Support the identification and development of outsourcing vendors and suppliers according to organizational quality standards and policies


    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

    QAQuality DocumentationCfrworkflowsProduct qualityManufacturing OperationsManufacturing ProcessReviewerManufacturingoperationscompliancePharmaceutical

    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

    Find them on

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    Assistant Manager, QA Reviewer · waiting for your command