QA Specialist- Fill & Finish Expansions Quality

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Gentofte

Are you passionate about cutting-edge technology and eager to shape the future of production at Novo Nordisk A/S? If you excel in international collaboration, possess pharmaceutical production expertise, and thrive on pushing process boundaries, you could be our ideal QA Specialist for global facility expansion. Join us! The Position As QA Specialist in validation for Biotech & Rare Disease (BRD), Fill & Finish Expansions (FFEx) Quality you will set the direction for quality assurance using Science- and Risk-based Validation (SRV) principles when implementing new aseptic production lines in our global network. Your responsibilities will range from the early definition of requirements to the final qualification. The main tasks will be to:
  • Ensure compliance with internal and external quality requirements and regulatory requirements (cGMP)
  • Set the scene for the quality mindset in the programme
  • Set direction for the validation strategy in BRD Expansions and for the individual work packages
  • Align with other areas within FFEx to ensure clear interface and roles.
    • You will be an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes. The department is new, hence changes in scope along the way may occur. Some international travel will be required. Qualifications To succeed in this role, you have:
  • Master’s degree in Engineering, Chemistry, Pharmacy or similar
  • Min. 5 years’ experience in aseptic/finished production in the pharmaceutical industry
  • Min. 5 years’ experience with validation or qualification, preferably as a QA person
  • IT and digitalisation knowledge & experience with science and risk-based validation
  • Proficiency in English, speaking and writing.
    • As a person you are a team player, organized and have solid problem-solving capabilities. You demonstrate a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure. You are a skilled communicator who can cooperate at any organizational level. Risk-based approach and the ability to balance compliance and product quality is no news to you. You are result oriented and have strong quality mindset. About the Department You will be joining Fill & Finish Expansions Quality. The area is anchored in Product Supply, Quality & IT, which globally employ approximately 20,000 of Novo Nordisk’s 50,000 employees. Fill & Finish Expansions is a newly established and growing area with the responsibility to design, plan and build all major fill & finish expansion projects across PSQIT to serve the needs of millions of patients. We do it by rethinking our fill & finish facilities with the use of modern technology. We are setting the standards for the facilities of the future, designing facilities we will still be proud of 20 years from now. Fill & Finish Expansions has a global approach, where you will be working with multiple sites and cultures across the world. Our department is responsible for quality assurance and compliance of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact QA Director, Klaus Castagni Parasole Volhøj at +45 3075 6137. Deadline Apply before October, 11 2023. We will conduct interviews on an ongoing basis, so do not hesitate to apply as soon as possible. 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 21.9.2023, men kan have været deaktiveret og genaktiveret igen.

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