QA Professional to support API Expansion Project

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Are you skilled in navigating complex stakeholder landscapes and do you believe in working together is better than working on your own? Do you value good team spirit where everyone is each other's sparring partners and respect each other's opinions and knowledge? Do you have a strong quality mind-set and great interpersonal skills and want to use all your solid QA experience in a project context. Then this is the right job for you. CMC API QA is looking for a new colleague to be part of an expansion project that is already running at full speed. The CMC API Pilot facilities are expanding their API production capacity for product to clinical trials, and we are looking for a new QA Professional to work with our QA colleagues allocated for this API expansion project. We offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally. For an introduction to the area we support - CMC API Pilots - please visit our career page The position In CMC API QA we make a difference for the lives of people participating in clinical trials in Novo Nordisk A/S, by ensuring that the products they receive are safe, of the highest quality and produced in compliance with legislation. As a department we continuously improve the quality of work and optimise our methods and processes to increase simplicity across CMC QA and CMC Development. As QA Professional you will be responsible for delivering best-in-class quality assurance on qualification of facilities and equipment according to Science Risk based Validation principals. This includes:
  • cross functional collaboration with scientists in the project and your QA colleagues
  • challenge and approve qualification documentation.
  • participate in workshops setting the quality direction for the project.
    • You will be part of a project team who treasure teamwork, diversity, and lots of humour despite an ever changing and busy work environment. When the expansion project is finalised in late 2025, you will transfer to the day-to-day support of the CMC API Pilot facilities handled by the CMC API QA Facility-Equipment team. Your key tasks will be challenging and approval of qualification documentation as well as other supporting documents for the CMC API Pilot facilities. Going forward you will participate in emerging investment projects to make our Pilot facilities more prepared for the future. Qualifications
  • You hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar.
  • You have 3+ years of experience within GMP and quality assurance.
  • You can work with several tasks at the same time and can make decisions and follow up on quality related problems. Preferably you also have experience with the Science Risk based Validation concept in Novo Nordisk.
    • As we operate both in a national and an international environment, you must speak and write Danish and English fluently. As a new colleague, the most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues with a necessary and sufficient mindset, make decisions and follow-up on quality related problems.  You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. As a person, you are self-driven and independent with a high sense of responsibility and initiative. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better. About the department CMC API QA is a department which employ 25 skilled and motivated colleagues divided in two teams both based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities as well as the release of raw materials, cell banks and API for clinical trials. We contribute as QA, in preparing our Pilot facilities for the future. You will be part of the Facility and Equipment team consisting of 11 QA professionals. The Team is QA responsible for the API pilot facilities assuring the quality of the facility and the Equipment. Our department values teamwork, diversity, and humour and we will make sure that you, as our new employee, feel welcome and included. A thorough individual training plan will be made for you together with your mentor. Working at Novo Nordisk Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 60,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Associate Manager Charlotte Hellesøe Ørtoft +45 3075 1742 or Sr. QA Professional Rune Munk Pedersen +45 3079 8106
    Deadline
    February 20, 2024 We will conduct interviews on an ongoing basis, so please submit your application as soon as possible as we might close the job posting before deadline. 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 26.1.2024, men kan have været deaktiveret og genaktiveret igen.

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