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Are you thrilled about working with modern technology, do you like to push the boundaries of production technology, and do you want to play a key role in the future of aseptic production in Novo Nordisk A/S?

Does close international collaboration and networking across boundaries come natural for you and do you have experience with science and risk-based validation?

Then you might be the QA Specialist we are looking for to support the establishment of our new aseptic production lines across the world.

The position

As QA specialist in AP Expansions Quality you will set the direction for quality assurance using SRV principles when implementing new aseptic production lines across the world. Your responsibilities will range from the early definition of requirements to the final qualification.

Other responsibilities include:

  • Ensuring compliance with internal and external quality requirements and regulatory requirements (cGMP)
  • Be an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes
  • Setting the scene for the quality mindset in the programme
  • Aligning with other areas within AP Expansions to ensure clear interface and roles
  • Setting direction for the validation strategy in AP Expansions and for the individual work packages

Some international travel will be required.

Qualifications

  • Master’s degree in Engineering, Chemistry, Pharmacy or similar
  • Minimum 5 years’ experience in aseptic production in the pharmaceutical industry
  • Minimum 5 years’ experience with validation or qualification, preferably as a QA person
  • Experience with science and risk-based validation
  • Excellent skills in collaborating with stakeholders from different cultures and organisational levels
  • Risk-based approach and the ability to balance compliance and product quality
  • Strong quality mindset and result orientation
  • Knowledge of IT and digitalisation
  • Proficiency in Danish and English, speaking and writing

As a person you are a team player, well organized and have solid problem-solving capabilities, just as you show 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.

About the department

AP Expansions Quality is a department in the newly established SVP area named AP Expansions. AP Expansions is working to increase the aseptic production capacity across the Novo Nordisk network to ensure we continue to deliver high quality products for our patients, also in the future.

We want to rethink our way of aseptic production and build something we can be proud of – also in 20 years from now.

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.

Contact

For further information, please contact Associate Manager, Tine Møller Jørgensen at +45 3079 1621 or email [email protected].

Deadline

Please submit your application no later than 04 November 2022.

Please note that interviews may start before the deadline, so feel free to submit your application as soon as possible.

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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Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Gentofte.

Jobbet er oprettet på vores service den 10.10.2022, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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