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    Advanced Business Analyst - Bengaluru, India - Novo Nordisk

    Novo Nordisk
    Novo Nordisk Bengaluru, India

    19 hours ago

    novo nordisk background
    Description
    The position

    As our Validation Lead, you will utilizing your extensive GxP experience ensure that the digital solutions we develop, systems/ processes meet and exceed regulatory standards.

    You will collaborate cross-functionally with different Line of Business across the organization to develop and execute validation strategies, protocols and reports.

    Key responsibilities
    • Lead validation activities for processes, systems, applications/digital solutions (CSV) in accordance with GxP regulations.
    Develop and execute validation plans, protocols, and reports, risk-based validation strategy, ensuring compliance with regulatory requirements. Provide guidance and expertise on validation best practices and regulatory standards. Performing compliance-related tasks including system documentation, review, and approval of CSV deliverables. Collaborate with cross-functional teams to integrate validation activities into the product development lifecycle. Participate in audits and inspections related to the project supported, including finding solutions to compliance gaps identified. Act as a liaison between Quality Assurance and system management to ensure system compliance requirements. Participate in system releases as a Validation SME. Drive continuous improvement initiatives to enhance validation processes and efficiency.

    Qualifications To be successful in this role, we are looking for candidates with the following qualifications:
    Bachelor's or master's degree (MCA, M.Sc., B.Sc., or similar) in Computer Science, IT Quality, or a relevant field. Industry-recognized certifications in ITIL and ISO quality management are preferred.

    Minimum 8+ years of experience in QA validation, with at least 5+ years of practical experience in GxP areas and 4+ years in performing CAPA, Change requests, and other relevant IT quality assurance activities.

    Excellent knowledge on regulatory requirements (cGMP etc) as well as internal requirements. Broad knowledge of basic IT technologies to be able to understand, and challenge decisions made by IT QA. Very good understanding of GDP & GAMP 5 standards. Detailed oriented mindset with a focus on quality and compliance. Proven track records of leading successful validation projects. Excellent communication and interpersonal skills with ability to collaborate effectively cross geographies/teams. Join us in our mission to deliver high-quality compliant products that improve patient outcomes About the department NN Quality GBS Unit
    • Our purpose is to make "Quality" simple, easy and understandable.
    Digital Quality team is one of the departments under NN Quality GBS, which is an extended team of Denmark.

    We in Digtial Quality- lead the digital transformation and drive digital innovation in NNQuality by providing a clear guidance on digitalization from a Q perspective and removing barriers towards digitalization.

    As a member of our unit, you will be part of an ambitious and dynamic group of over employees who ensures "highest quality to patients".

    Working at Novo Nordisk Novo Nordisk is a leading global healthcare company with a -year legacy of driving change to defeat serious chronic diseases.

    Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily.

    All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63, employees around the world.

    We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them.

    Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.
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