Novo Nordisk
IT Equipment Validation Lead
Are you ready for a unique opportunity to shape the validation direction for Laboratories of the Future in Novo Nordisk? Do you have a quality mindset and are you eager to contribute your energy and talent in a in a highly engaged team? Then join us as Equipment Validation lead in Analytical IT, CMC.
The position
You will be part of a team that works to implement, validate and support Laboratory IT Solutions. We have a natural desire to always look for smarter ways of doing things and are always working to contribute to improving Novo Nordisk’s standards and services.
Your daily tasks and responsibilities will be to:
Lead and participate in projects as responsible for the end-to-end direction and quality with respect to IT & Validation
Work collaboratively across functions with Quality Assurance, IT, Line of Business and vendors to plan, coordinate and execute computer system validation activities
Perform risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes
Drive IT projects and participate and large automation/digitalisation groups
Have the ownership for the development and delivery of complete validation packages, incl. IT Risk Assessment
Facilitate verification and validation activities including test execution, documentation review and approval
Seeking new ways of working by simplifying and improving the processes
Qualifications
We expect you to have:
A relevant academic background and relevant experience with GMP and validation of equipment.
Experience or interest within pharmaceutical Quality Management, or you have taken part of GxP system validation and wish to grow in your profession. Also experience or interest within Azure DevOps, TIMS3
Knwoledge of the guidelines provided by the global regulatory agencies and authority agencies such as FDA in areas such as GxP, 21CFR part 11, GAMP Annex11 etc.
Good knowledge about GAMP framework
Solid project management skills
As a person you embody a team-oriented, self-driven, and proactive approach, taking responsibility for your actions. You value open communication, fostering healthy discussions while guiding towards a shared direction. Adaptability is key, as you thrive amidst frequent changes and actively seek and provide feedback. Your willingness to challenge existing business processes and collaborate closely with stakeholders demonstrates your commitment to growth and innovation.
About the department
As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set. The department CMC data, Technology & IT is part of the Novo Nordisk Product Supply family, and you will be able to use your skills and talent not only in our department, but across the entire field.
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