QA Professional

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Do you master GMP, and Quality related to packaging and supplying products for clinical trials - or are you eager to master this? Are you a truly skilled and proficient person? Then I may have just the right job for you. The job You will work as QA for the Clinical Supplies area, with 19 engaged, highly professional new QA colleagues. The area we support is the area within Novo Nordisk setting up the labelling, packaging the products and handling the full supply chain for the clinical trials run worldwide. Depending on your background you will initially work with certain parts of the QA process related to this, but your development both within our own area of QA disciplines as well as within Novo Nordisk is on top of my agenda from day one. You will act as a QP delegate to certify and release the final packaged product from both NN clinical packaging facility as well as from external contract manufacturing organisations. In that role you will also support the QP and the Clinical Supplies area with other issues that needs QP or QP delegate involvement. We work at the borderline of GMP and GCP and you must be able to asess both aspects of regulations and reach out to obtain knowledge at this borderline. Regulations and ways of setting up and conducting clinical trials are evolving with high speed these years, so you must be able to adapt to and enjoy these changing times within your daily work. Depending on you level of experience and ability to act across different subject matters, you will contribute to improvement projects both internally with our stakeholders and across the NN Quality organisation where we continuously strive towards taking the NN Quality processes to the next level. Qualifications We are looking for candidates with 2 key qualifications. The educational part is mandatory.
  • Master’s degree in pharmaceuticals, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry or biology eligible to work as Qualified Persons delegates according to DMA guidelines (mandatory - applicants not living up to this will not be considered)
  • As a minimum 2 years of experience with GMP (QA, QC or production) from company with Manufacturing and Import Authorisation
    • You have solid stakeholder management skills and flair for handling conflicting interests and evaluate issues from several perspectives. You must be able to take and communicate decisions in an effective way. The ability to work and deliver results independently and at the same time be a true team player is key to your success in the role. 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 40,000 employees. Together, we go further. Together, we’re life changing.’ Contact For clarifications or questions, please do not hesitate to contact Birthe Rottwitt (+45 30750158) About the area Novo Nordisk portfolio is growing and diversifying as ever before. Numbers of patients, countries and sites participating in our clinical trials are increasing. The ways of collaborating within and outside of NN is changing rapidly, also within the Quality area. Thus, we are seeking a new colleague in CMC Clinical Supplies QA to be part of this fantastic journey. Deadline August 1st. I will look at applications and perform interviews continuously - and hire if the perfect match is found prior to this deadline. It might be you. We are eager to welcome our new colleague. 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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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Måløv.

    Jobbet er oprettet på vores service den 7.6.2023, men kan have været deaktiveret og genaktiveret igen.

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