Sr.IT Validation

The position

As a Senior IT Validation & Compliance Specialist I at Novo Nordisk, you will have the following responsibilities: Act as an SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary. Perform various assessments including IT Risk Assessment (ITRA), IT Requirements Risk assessment (ITRRA) Quality, functional, data integrity and supplier assessments. Participate in Global forums to provide quality and process inputs and share knowledge within and outside department. As a compliance SME, provide trainings or share knowledge in global forums. Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV/ CSA. Qualifications To be successful in this role, you should have the following qualifications: MCA, M.Sc., B.SC. BE or similar graduate degree in relevant field. Overall experience of more than 10+ years in the IT or equivalent industry. Minimum 10+ years of experience in working in a pharmaceutical /service-based organization preferably in the IT quality domain. Minimum 5+ years of practical experience in GxP areas with exposure to regulatory requirements. Minimum 5+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities. Good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11. Ability to represent NN in relations with users and external stakeholders. 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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