IT Validation Lead
3 weeks ago
We are seeking a highly skilled IT Validation Lead to join our team at Novo Nordisk Digital Data & IT (DD&IT). As a key player in our dynamic team, you will be responsible for defining and executing validation and qualification strategies for GxP and non-GxP Computerized Systems.
Key Responsibilities- Develop and execute validation plans, including validation protocols and risk assessments.
- Conduct assessments of suppliers, IT risks, and functional and data integrity risks.
- Maintain system validation through regular reviews, deviation handling, and collaboration with System Managers and IT personnel.
- Ensure compliance with relevant internal and external regulatory requirements.
- Foster strong relationships with colleagues and stakeholders through effective communication.
- Bachelor's degree in Engineering, Chemistry, Pharmacy, IT, or a related field.
- Extensive experience in Computer System Validation (CSV) or manufacturing/production experience with a recognized GMP certificate/qualification.
- Strong knowledge of IT GxP validation, preferably in a regulated industry such as pharma or healthcare.
- Relevant certifications such as GAMP5, CSQE, CVP, CQA, CQE, CRMA, CISA, or CRISC.
- Excellent communication and interpersonal skills.
Novo Nordisk is a global healthcare company headquartered in Denmark. We have been driving change to defeat diabetes and other serious chronic diseases for 100 years. Our treatments benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases.
We are proud of our people and employ over 60,000 bright and diverse minds in 80 offices worldwide. We offer a rewarding and purpose-driven culture where your professional and personal development is highly valued.
Join us in our mission to make a difference in the lives of people worldwide.
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