Senior IT Validation
2 weeks ago
About the Role
We are seeking a highly skilled Senior IT Validation & Compliance Specialist to join our Digital Quality Transformation team at Novo Nordisk. As a key member of our team, you will be responsible for ensuring the quality and reliability of our IT systems, while also driving digitalization and quality improvements across our organization.
Key Responsibilities
- Act as an SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary.
- Perform various assessments including IT Risk Assessment (ITRA), IT Requirements Risk assessment (ITRRA) Quality, functional, data integrity and supplier assessments.
- Participate in Global forums to provide quality and process inputs and share knowledge within and outside department.
- As a compliance SME, provide trainings or share knowledge in global forums.
- Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV/ CSA.
Requirements
- MCA, M.Sc., B.SC. BE or similar graduate degree in relevant field.
- Overall experience of more than 10+ years in the IT or equivalent industry.
- Minimum 10+ years of experience in working in a pharmaceutical /service-based organization preferably in the IT quality domain.
- Minimum 5+ years of practical experience in GxP areas with exposure to regulatory requirements.
- Minimum 5+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities.
- Good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11.
- Ability to represent NN in relations with users and external stakeholders.
About 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. 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.
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