IT Quality Assurance Lead for Pharmaceutical Industry
7 days ago
Novo Nordisk is a leading global healthcare company with a strong legacy of driving change to defeat serious chronic diseases.
Job SummaryWe are seeking an experienced IT Quality Assurance Lead to join our team in the pharmaceutical industry. As a Senior IT Validation & Compliance Specialist I, you will be responsible for executing the validation strategy, performing assessments, and providing compliance consulting for IT projects.
Responsibilities- Act as a Subject Matter Expert (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 the department.
- As a compliance SME, provide trainings or share knowledge in global forums and provide compliance consulting for the IT projects.
- MCA, M.Sc., B.SC. BE or similar graduate degree in a 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 Novo Nordisk in relations with users and external stakeholders.
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience.
About Working at Novo NordiskWe recognize the importance of unique skills and perspectives and work continuously to bring out the best in our people. Our success relies on joint potential and collaboration, and we're working toward something bigger than ourselves. Join us and together, we can make a difference.
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