Job Description

Department: DD&IT Development

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!

The Position

As Specialist-ITIL, you will work with Infra Squad within Clinical Site & Patient Facing ART (Agile Release Train) and will be part of an agile team where you will be responsible for the delivery of system and support services and ensuring that they meet business requirements and be part of SAFe Agile team and work in agile framework to deliver value. You will be entrusted with below responsibilities:

• Understand the interface within clinical system landscape and work along with team in ensuring validated state of product by acting as liaison between Quality Assurance and the product team to assure that the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines are met.
• Participate in system releases while performing Validation responsible role with technical understanding reviewing Quality Risk Assessment, a coordination / Validation and Defect Management, etc, meeting the Quality & Compliance requirements as per company QMS procedures and regulatory guidelines.
• Support product owner on the team as and when required. Demonstrate pro-activeness and ownership. Should take complete ownership for the tasks and drive to completion. Understand business complexities and different perspectives of the same.
• Handling Change Request to comply with the Change management work instructions. Support system releases while performing as Release Manager & validation responsible role, as applicable. You will be monitoring the effectiveness of incident and problem management process and make recommendations for improvement.
• Manage global stakeholders which include internal parties (Product managers/Product Owner area, System Owners, Department Manager, etc.) and external parties (customer, consultants, vendors, etc.) for high level collaboration.

Qualifications

• You should hold a master\xe2\x80\x99s/bachelor\xe2\x80\x99s degree or similar graduate degree in relevant field (Computer Science, Business Administration or equivalent) with experience ranging between 8 years and 10+ years in overall.
• Minimum 4 years\xe2\x80\x99 experience working in pharmaceutical /IT industry having 4+ years of relevant technology and GxP regulated Industry experience (Quality and IT, experience in GAMP,21 CFR part 11 validation concepts in pharmaceutical industry).
• Good understanding of clinical drug development process.
• Good understanding of Automation testing.
• Good experience in GAP Analysis and documenting remediation plan along with Vendor Management and Stakeholder management.
• Understanding of MuleSoft Platform and the basics of API development will be brownie point.

About the department

In DD (Digital, Data) &IT Development Clinical Site & Patient Facing Solutions, a part of Global IT GBS, a portfolio of GxP, financial & 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. DD&IT Development Clinical Site & Patient Facing 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.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We\xe2\x80\x99re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things \xe2\x80\x93 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\xe2\x80\x99re 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).

Deadline

9 Oct 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\xe2\x80\x99re life changing.

Novo Nordisk