Job Description

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IT Val. & Comp. Specialist I
Category: Digital & IT
Location:
Bangalore, Karnataka, IN
Department - Submissions, Labelling & Translations solutions - Digital Data (DD) & IT Development GBS
Are you experienced in IT validation and compliance within the pharmaceutical industry? Are you looking for a new challenge in a global healthcare company? We are seeking an IT Validation and Compliance Specialist I to join our DD&IT Development GBS Regulatory Solutions at Novo Nordisk. If you have a strong background in computer system validation and a passion for ensuring regulatory compliance, then read on and apply today for a life-changing career.
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About the department
In DD&IT Development GBS - Submissions, Labelling & Translations 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. We work 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 IT Validation and Compliance Specialist I, at Novo Nordisk, you will have the following responsibilities:

• Work closely with Line of business, DevOps team, Vendor, IT Quality Assurance (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.
• Drive the releases and validation activities required for the release and drafting test cases.
• Successfully migrated the existing IT Risk Assessment to ServiceNow and handling of Deviations, Support team in validation activities.
• Managing yearly reports reviews, update, 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
To be successful in this role, you should have the following qualifications:

• You hold bachelor or Masters in relevant field with total of 10+ years of experience in IT.
• Minimum 7 years of GxP Validation/Testing experience in working with pharmaceutical requirements and 4+ years of Software testing experience.
• Experience in Agile methodology, usage of Azure Devops (ADO) etc.
• Experience in drafting test cases & reviewing test cases and approving test cases in Leapwork. Scheduling runs and having ext Information Management System (TIMS) integration setup along with Leapwork tester for Publishing go-live project using automation tool - Leapwork for Publishing.
• Good to have Certification of Scaled Agile Framework (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 Nordisk
Novo Nordisk is a leading global healthcare company with a 100-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 64,000 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 are working toward something bigger than ourselves, and it\'s a collective effort. Join us! Together, we go further. Together, we are life changing.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Apply Now!
Deadline
5 July 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\'re life changing.