Job Description

Job description Department - CVT Compliance CoE II Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is es

Job description Department - CVT Compliance CoE II Does your motivation come from challenges and working in a dynamic environment Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential Do you have a can-do attitude with continuous improvement as one of your career objectives Then we might have the right position for you. Apply now and join a growing team, The Position As an Advanced Business Analyst, you are expected to perform varioustasks related to Computerized System Validation (CSV) and IT Compliance: Perform compliance related tasks provided as services from the department and develop plans, execute, and deliver the services with acceptable service evaluations. Perform stake holder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV. Able to perform CAPA and RCA using 5 x Why approach or any similar approach and take up IT Quality co-ordinator roles at various stages of IT project. Qualifications You hold a bachelor's/ master's degree (Computer/Science/IT quality) with 6+ years of experience working in a service-level based organisation preferably in IT quality domain. Min 4+ years of practical experience in GxP areas with exposure to regulatory affairs. Min 4+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities. Excellent knowledge on regulatory requirements as well as internal requirements to keep systems within responsibility in compliance. Broad knowledge of basic IT technologies to be able to understand, and challenge decisions made by IT QA. Very good understanding of GAMP and knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11) About the department Cross IT Services is the unit responsible for compliance management of IT systems at Novo Nordisk in areas like Global IT, PS, CMC etc. The systems are used on a global scale by many areas of the business, including R&D, Patient Safety etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance, etc. This unit is responsible for validating these systems/ Qualification of underlying infrastructure and maintaining the validation status. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease. Contact To submit your application, please upload your CV online (click on Apply and follow the instructions). Apply Now! Deadline 11th October 2022 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.