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    Specialist - Quality Operations

    REQ-10015176
    9月 03, 2024
    India

    摘要

    -Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.  

    About the Role

    Job Description

    Major accountabilities:

    • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

    Key performance indicators:

    • On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration  

    Minimum Requirements:
    Work Experience:

    • Functional Breadth.
    • QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
    • Collaborating across boundaries.
    • cleanliness zones.

    Skills:

    QMS

    BMR/ BPR review

    Batch Release process

    Quality Management

    Regulatory compliance checks

     

    Languages :

    • English.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

    Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

    Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

    A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
    REQ-10015176

    Specialist - Quality Operations

    Apply to Job

    Source URL: https://www.bkartpay.com/careers/career-search/job/details/req-10015176-specialist-quality-operations

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    2. https://talentnetwork.novartis.com/network
    3. https://www.novartis.com/careers/benefits-rewards
    4. https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/Specialist---Quality-Operations_REQ-10015176
    5. mailto:[email protected]
    6. https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/Specialist---Quality-Operations_REQ-10015176