Specialist I
3 weeks ago
The position
As a Specialist I – SAP and New Gen Tech IT Compliance Lead, you will have the following responsibilities: Take ownership of SAP S/4 HANA implementation, ensuring quality and compliance throughout the entire process. Define and execute validation strategies for both the project and operations phases. Perform qualification activities, including implementation plans, design reviews, and test strategies. Conduct assessments, such as supplier assessments, IT risk assessments, and functional and data integrity assessments. Create and author relevant standard operating procedures (SOPs) and guide product teams on deviation handling and support audits and inspections. Collaborate with NN quality and compliance to ensure timely closure and approval of validation deliverables. Support compliance and validation activities for new generation technologies like Artificial Intelligence (AI)/ Machine Learning (ML) and Blockchain and create and author guidelines and SOPs to ensure compliance during the operational phase. Qualifications To be successful in this role, we are looking for a candidate with the following qualifications: You hold a Masters/bachelor’s with 10+ years of experience working in a service level-based organization, preferably in the IT quality domain. 6-7 years of experience in SAP, specifically SAP S/4 HANA implementation in compliance with pharmaceutical regulations. Good understanding of GAMP 5 Guide and various regulatory requirements, including CFR part 11 and EU Annex 11. Familiarity with ITIL processes, especially Change, Release, and Configuration management. Experience working with Agile frameworks. Excellent communication skills in English and comfortable working with different cultures. Ability to collaborate and communicate with stakeholders, both internal and external at all levels. About the department CVT CoE is a as part of the DD&IT Services department, and is the unit responsible for supporting compliance, validation and testing of multiple IT systems and solutions across Novo Nordisk. The systems are used on a global scale across business areas and are critical to the execution of key business processes such as development, manufacturing, sales, finance etc. CVT CoE focuses on delivering harmonized support services related in the Compliance, Validation and Testing areas. 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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Specialist I
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bangalore, India Novo Nordisk Full timeThe position As a Specialist I – SAP and New Gen Tech IT Compliance Lead, you will have the following responsibilities: Take ownership of SAP S/4 HANA implementation, ensuring quality and compliance throughout the entire process. Define and execute validation strategies for both the project and operations phases. Perform qualification activities,...
