IT Validation Responsible

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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 an IT Validation Responsible in Analytical IT. Apply now! The position A key part of the position will be to be involved in a large automation project (+50mdkk 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. Contact For further information, please contact Manager, Hamza Bakir at +45 3075 3033. Deadline 20 August 2023 Applications will be reviewed continuously, and we will begin conducting interviews already during the posting period, so please do not hesitate to apply. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Jobbet er oprettet på vores service den 20.7.2023, men kan have været deaktiveret og genaktiveret igen.

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