API Manufacture Quality Specialist

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Kalundborg

In Novo Nordisk, we are investigating new API (Active Pharmaceutical Ingredients) manufacturing facilities to support the company portfolio of future oral and injectable pharmaceuticals. Would you like to join a dynamic global company and work on an exciting new project? Are you interested in the opportunity to establish potential new API manufacturing facilities that bridge new and automated technologies with strong know-how and expertise in biotech manufacturing? And would you like to be the specialist defining the batch reporting and batch status assignment? Then this might be the position for you. Apply today and join us for a life-changing career! The position
As a Specialist within the Project Quality team, you will be overall responsible for establishing the set-up for batch reporting across all processes within our upcoming facilities. You will:
  • set the direction on batch split with regard to logistical, process, IT, and quality requirements and procedures based on the release by exception principle
  • need to use your innovative mindset to create an efficient and simple batch reporting process end-to-end – leading to fast and predictive batch release (approaching “instant release”)
  • be at the forefront of designing the entire release process in our new facilities – using both your quality knowledge and LEAN mindset
  • must exercise strong leadership to establish a cross-unit team working to establish specifications for batch reporting
  • work with several stakeholders – both within own newly established user organization but also with engineering partners working on IT and automation and several corporate functions
  • be responsible to prepare the required documentation – both for quality purposes and also for different internal decision-makers
  • Qualification To be considered for this position, you should have:
  • Minimum of 6 years of experience in API processes and GMP, along with a master's level education in process engineering or a similar field.
  • Profound knowledge of IT systems and processes used in GMP manufacturing.
  • The ability to analyze complex data and processes and convert them into efficient and simplified processes.
  • Strong and impactful communication skills.
  • A high quality mindset, allows you to balance requirements with an efficient and lean batch reporting and release process.
  • Proficiency in English, both verbally and in written communication.
  • On a personal level, you are a strong motivator of others and thrive in setting up new processes. You enjoy working in a multicultural environment that demands independence to make critical decisions. Building structure comes naturally to you, and you enjoy simplifying wherever simplicity can benefit in reaching the right goals faster. About Novo Nordisk Kalundborg Today, 3,200 employees of Novo Nordisk Kalundborg produce half of the world’s insulin and several biopharmaceutical products. With more than 50 years of expertise in large-scale biotech manufacturing, we are today the world’s largest insulin-producing facility. By joining Novo Nordisk Manufacturing in Kalundborg, we promise you a developing career, where you will be met with trust and responsibility by dedicated colleagues with diverse backgrounds in a successful company with a higher purpose and an inclusive environment. Together, we make a difference every day for more than 30 million people living with diabetes and other chronic diseases. 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 letting perfection stand in the way of good. We never shy away from opportunities to develop, we seize them. From research and development, to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact F or further information, please contact Senior Project Manager Mie Boa Jacobsen at +45 3075 1354. Deadline 17 September 2023. We will review applications on an ongoing basis, so please apply as soon as possible, as we would like to fill the position as soon as possible You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to apply in your CV.  To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.


    Information og data

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

    Arbejdsstedet er beliggende i Kalundborg.

    Jobbet er oprettet på vores service den 23.6.2023, 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.
    • Øvrige
    • Kalundborg

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