Validation Specialist

1 week ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk Full time
About the Role

We are seeking a highly skilled Validation Specialist to join our team at Novo Nordisk. As a key member of our M3 IT/Automation department, you will play a critical role in ensuring the compliance and validation of our IT systems and computerized equipment.

Key Responsibilities
  • Validation Strategy and Planning: Develop and implement validation strategies for IT systems and computerized equipment, ensuring compliance with GxP regulations.
  • Validation Execution: Lead the execution of validation activities, including planning, documentation, coordination, and reporting.
  • Quality Control and Assurance: Ensure the validated state of systems by performing periodic reviews, addressing deviations, and maintaining system documentation.
  • Collaboration and Communication: Work closely with IT/Automation experts, project managers, and quality assurance teams to ensure effective communication and collaboration.
Requirements
  • Education: Bachelor's degree in Automation, IT, Biotechnology, Production Engineering, or a related field.
  • Experience: Minimum 2 years of experience in validation from the pharma industry or other regulated industries, with GxP compliance experience.
  • Skills: Strong understanding of GAMP and IT/OT systems, excellent communication and collaboration skills, and ability to work in a dynamic environment.
About Novo Nordisk

Novo Nordisk is a global healthcare company with a passion for improving patients' lives. We are committed to creating an inclusive culture that celebrates diversity and promotes equality of opportunity for all our employees.



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