Sr.IT Validation And Compliance Specialist I

Department : Digital Quality Transformation
Are you passionate about IT validation and compliance? Do you have a knack for ensuring systems meet regulatory requirements? We are looking for a Senior IT Validation and Compliance Specialist I to join our Digital Quality Transformation team at Novo Nordisk. If that sounds like you, read on and apply today for a life:changing career.
About the department
Enterprise Platforms and Technology Services is a unit within DD and IT that provides end:to:end IT solutions for various business domains across Novo Nordisk. The unit consists of functions like Enterprise Platforms, SAP Integration, Digital Quality and Testing services Center Of Excellence (CoE), Validation Services and Automation CoE, Poland hub and Mexico hub. Digital Quality and Testing Services CoE is a unit within Enterprise Platform and Tech services that focuses on delivering high:quality and efficient testing services for various IT projects and systems. The unit follows the best practices and standards of software testing, including test automation, performance testing, functional testing, and user acceptance testing. The unit also ensures compliance with the regulatory requirements and guidelines for computerized system validation (CSV) and data integrity. The unit works closely with the business stakeholders and the IT project teams to ensure the quality and reliability of the IT solutions delivered by Novo Nordisk. The Digital Quality Transformation department is anchored in the Digital Quality and Testing service CoE. The main responsibility of the dept is to drive digitalization and quality improvements across our IT systems. The team is focused on ensuring compliance and leveraging innovative approaches to enhance our IT quality processes. With a collaborative atmosphere and a commitment to excellence, we strive to support the long:term strategy and growth of Novo Nordisk.
The position
As a Senior IT Validation and Compliance Specialist I at Novo Nordisk, you will have the following responsibilities:
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Act as an SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary.
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Perform various assessments including IT Risk Assessment (ITRA), IT Requirements Risk assessment (ITRRA) Quality, functional, data integrity and supplier assessments.
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Participate in Global forums to provide quality and process inputs and share knowledge within and outside department.
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As a compliance SME, provide trainings or share knowledge in global forums.
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Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV/ CSA.
Qualifications
To be successful in this role, you should have the following qualifications:
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MCA, M.Sc., B.SC. BE or similar graduate degree in relevant field.
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Overall experience of more than 10 years in the IT or equivalent industry.
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Minimum 10 years of experience in working in a pharmaceutical /service:based organization preferably in the IT quality domain.
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Minimum 5 years of practical experience in GxP areas with exposure to regulatory requirements.
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Minimum 5 years in performing RCAs, CAPA and any other relevant IT quality assurance activities.
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Good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11.
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Ability to represent NN in relations 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
Job Type: Permanent