IT Equipment Validation Lead

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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 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.   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 Associate Manager, Mia Nygaard Daae at +45-30797954   Deadline 31 July 2024   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 6.6.2024, men kan have været deaktiveret og genaktiveret igen.

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