IT Validation & Compliance Specialist I

Department – DD&IT Staffs GBS

Are you passionate about IT validation and compliance? Do you have a knack for ensuring systems meet regulatory requirements? We are looking for a IT Validation Specialist to join our DD&IT Staffs GBS team in Corporate Facilities (CFA) HQ systems. If you are ready to take on this exciting challenge, read more and apply today for a life-changing career.

The position 
As an IT Validation & Compliance Specialist I at Novo Nordisk, you will have the following responsibilities:

• Participate in system releases, perform validation roles, and ensure that documentation and verification activities meet quality and compliance requirements as per the Quality Management System (QMS) and regulatory guidelines. Collaborate with the Quality Assurance team to fulfil overall quality assurance responsibilities.
• Ensure configuration documents are updated, participate in annual periodic reviews, and represent the system during internal and external audits. Manage audit preparation and representation, if required.
• Ensure all compliance deliverables meet specified requirements in content and form, approving them in accordance with defined standards. Understand system complexity from a quality and compliance perspective and support system operation and maintenance.
• Coordinate the validation process for system changes and releases, collaborating with Line of Business (LOB) and system management teams. Take ownership of associated documentation activities.
• Manage compliance and documentation for IT operations, changes, problems, and incidents that impact the system. Work closely with stakeholders to ensure adherence to standards, regulatory requirements, and GxP processes for change management and implementation.

Qualifications
To be successful in this role, you should have:

• Bachelor’s or master’s degree in a relevant field with 10+ years of experience in IT or the pharmaceutical industry, including system management experience and a strong understanding of GxP systems.
• Should have a strong understanding of compliance and documented GxP experience across multiple systems, along with a solid background in validation and IT infrastructure, including expertise in databases, networking, and server management up to the OS level.
• Experience in ITIL processes with strong expertise in change management to assess the impact of system changes and provide validation support for PACS, including validation planning, documentation as per SOP, test case authoring, review, and approval.
• Should have knowledge of compliance activities, including design, development, testing/validation, documentation, implementation, and maintenance of IT solutions in large organizations. Must have experience managing medium-sized upgrade projects or similar initiatives.
• Experience working with agile delivery models and should have experience in performing Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and other relevant IT quality assurance activities.
• Excellent interpersonal and communication skills including verbal and written communication. Ability to represent NN in relation with users and external stakeholders.

About the department
You will join our Digital Data (DD)&IT Staffs GBS team of professionals anchored in GBS Bangalore, collaborating with the Design & Deliver team on projects across the Staffs area. The team is responsible for managing day-to-day IT support, development, validation and testing of entire Quality Management System of Novo Nordisk, spanning across entire globe. The key objective is to ensure robust IT support to systems, which in turn ensures product quality and patient safety for Novo Nordisk.

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 63,000 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’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.

Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Apply Now!

Deadline
3 January 2025.

Disclaimer

It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.

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.