The positionA key part of the position will be to be involved in a large automation project (mdkk investment) building the IT infrastructure for laboratories of the future in Novo Nordisk. The objective is to create fully automated Quality Control (QC) work-cells / lines in CMC and subsequently scale the to the rest of the company. Your daily tasks and responsibilities will include: Leading and participating in projects as responsible for the end-to-end direction and quality with respect to IT & Validation Working collaboratively across functions with Quality Assurance, IT, Line of Business and vendors to plan, coordinate and execute computer system validation activities Performing risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes Driving IT projects and participate and large automation/digitalisation groups Having the ownership for the development and delivery of complete validation packages, including IT Risk Assessment Additionally, our new IT Validation Responsible will facilitate verification and validation activities including test execution, documentation review and approval , and seeking new ways of working by simplifying and improving the processes. Qualifications Our ideal candidate posses a relevant academic background and at least 2 years of relevant experience with GMP and validation. Additionally, we expect you to have: Experience or interest within pharmaceutical Quality Management, or have taken part of GxP system validation and wish to grow in your profession. Also experience or interest within Azure DevOps, TIMS3 Been working with 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 Good communication skills in Danish and English As a person, we are looking for someone who is team-oriented person , self-driven, proactive, and responsible. You are willing to bring your thoughts out in the open, creating a healthy discussion, and at the same time, setting a direction. It is crucial to be able to operate with frequent changes. You are open to giving and receive feedback, challenging the business processes and willing to collaborate close with stakeholders. About the department 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. 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. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales.
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