Job Description

At Novo Nordisk, we strive to be at the forefront of digital healthcare and to succeed with this, we need many bright minds. Working directly or indirectly with all parts of Novo Nordisk Globally, you will play a significant part in leading Novo Nordisk towards the future of digital healthcare securely. We are looking for an Advance Business Analyst- I for our Regulatory Solutions, DD & IT Development GBS. Join a growing team, working in an international environment. Apply now!About the departmentIn DD&IT Development GBS Regulatory Solutions, a part of DD&IT GBS, a portfolio of GxP & business critical applications is being managed and supported. These applications are among the most critical IT systems in Novo Nordisk supporting essential processes and being used 24x7 by thousands of users worldwide. Regulatory Solutions works closely with line of Business, System managers, Quality Check (QC)/Quality Assurance (QA) and subject matter experts across the Novo Nordisk IT organization in Denmark and India. We work in Submissions and Labelling (SuLa) ART.The Position -As an Advance Business Analyst \xe2\x80\x93 I, you will be responsible as Validation Responsible for system maintenance of Centralised Translation or Global Link System. Centralised Translation or Global Link System is implemented in line with our global process (Q110180) for translation management and it is developed and delivered in collaboration with one of our preferred translation vendors (Transperfect). This system is a NextGen Translation Management System which enables user to translate various documents into desired target language. You will be entrusted with the below responsibilities:

• Work closely with Line of business, DevOps team, Vendor, IT QA, Leapwork team and other relevant stakeholders involved in the project.
• Responsible for preparing the Release plan for releases and driving all the release related activities (preparing the implementation plan, participating in the impact assessment meetings, updating & review of CS, URS & FSDS for releases, updating CIL and other relevant impacted documents.)
• Drive the releases and validation activities required for the release and drafting test cases for IV and executing them during the releases, then reviewing and approving the OV & PV test cases and reviewing the OV & PV test runs during the releases.
• Successfully migrated the existing IT Risk Assessment to ServiceNow and handling of Deviations, Support team in validation activities.
• Managing yearly reports reviews, update of O&M SOP, Keep Audit Checklist, all compliance documents, Risk Assessment document up to date. Present and share quality related subjects to the team and act as system manager backup as needed.

Qualifications

• Bachelor or Masters in relevant field with total of 10+ years of experience in IT.
• Minimum 5.5 years of GxP Validation/Testing experience in working with pharmaceutical requirements and 4+ years of Software testing experience.
• Must have experience in Agile methodology, usage of ADO etc.
• Experience in drafting test cases & reviewing test cases and approving test cases in Leapwork. Scheduling runs and having TIMS integration setup along with Leapwork tester for Publishing go-live project using automation tool \xe2\x80\x93 Leapwork for Publishing.
• Good to have Certification of SAFe 5 Practitioner.
• Excellent interpersonal and communication skills including verbal and written communication.
• Ability to represent NN in relation with users and external stakeholders.

Working at Novo NordiskNovo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That\xe2\x80\x99s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working towards something bigger than ourselves, and it\xe2\x80\x99s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we\xe2\x80\x99re life changing.ContactTo submit your application, please upload your CV online (click on Apply and follow the instructions).Deadline29 March 2024.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\xe2\x80\x99re life changing.

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