Job Description

Job description Department - Cross IT Services Does your motivation come from challenges and working in a dynamic environment Do you thrive in a working environment where customer centric service delivery is the key strategic alignment with key stakeholders is essential Do you have a knack for business intelligence and automation platforms and 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, working in an international environment. About the department Cross IT Services is the unit responsible for compliance management of systems at Novo Nordisk in areas like: Global IT, PS, CMC, NNIO and NNI etc. The systems are used on a local, regional, and global scale by many areas of the business, including R&D, Sales and Marketing, Production sites etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance, etc. This unit is responsible for validation these systems/ Qualification of underlying infrastructure and maintaining the systems in the validated state throughout in its operation. The Position As the Advanced Business Analyst I, you will be responsible for Computerised System Validation (CSV) including definingrisk-based validation strategy & authoring deliverables for multiple projects, perform Root Cause Analysis (RCA) using 5x or any other similar approach and suggest/ implement Corrective and Preventive Actions (CAPA).You will be entrusted with below responsibilities on a high level: Develop plans, execute, and deliver the services with acceptable service evaluations. Perform gap assessments against current 21 CFR Part 11 and EU Annex 11 regulatory requirements. Involve in the Supplier Evaluation process, review contracts to make sure that the quality parameters are defined clearly. Prepare Agile/IT implementation plan/report, execute the plan, author/review validation deliverables. Prepare IT Quality Risk Assessment and drive the Quality Risk assessment including finding appropriate actions for the risks identified. Prepare Qualification Protocols/Reports and Perform test execution, review, and reporting. Review and approve/ acknowledge (on behalf of NN QA) validation deliverables including Installation Verification (IV), Operational Verification (OV), Performance Verification (PV) etc. Qualifications Bachelors\' or Masters\' in relevant field with 7-10 years of experience working in a Pharmaceutical/ Device Manufacturing/ Service based organizations preferably in the IT quality domain. Minimum 3+ years of practical experience in GxP areas with exposure to regulatory requirements. Minimum 3+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities. Preferred Industry recognized ITIL and ISO quality management certification. Excellent communication skills in English and comfortable working with different cultures. Good knowledge in 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 5, Data Integrity by Design etc.. Very good knowledge and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11, EU Annex 11). Exposure to Test management tools such as HP ALM, Azure DevOps, etc. Experience with implementation if IT Systems in both waterfall and Agile methodology. 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 7th April 2023 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.

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