GMP Documentation Management Professional

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Are you an experienced Documentation professional, with a passion to continuously leverage quality, are you motivated by responsibility and working with a variety of internal stakeholders? Then read on, as we are looking for you, who are able to convey the importance of qualifying and documenting suppliers and products according to GMP requirements – and are a wizard doing so. If you see yourself getting energized by putting documentation first at Novo Nordisk Pharmatech – for the indirect benefit of 600 million of lives worldwide - then apply today! The position You will become part of a team of 14 Inbound Supply colleagues, who are responsible for vendor management of raw materials, process aids and managing CMOs. The team is likewise responsible for supply and qualification of new materials and/or suppliers in relation to product launches. The Inbound Supply team is part of the Supply Chain and Procurement, that likewise covers Warehousing, Indirect Procurement, and Production Planning. This is a key role supporting Inbound Supply with critical documentation of existing and potential suppliers, products and processes in close collaboration with a variety of internal stakeholders to make quality and regulatory ends meet timely. You drive processes to help and support your colleagues to provide their input for the documentation package, by identifying, collecting, and providing appropriate GMP documentation, as well as enabling continuous optimization of the sourcing documentation process. This entails - but is not limited to-:
  • Being responsible for documentation packages, by supporting stakeholders in applying the GMP language in alignment with QA requirements.
  • Collaboration and coordination across the organisation to collect information and documentation for each documentation package.
  • Handling Change Notifications, Deviations or Change Requests.
  • Identifying documentation gaps, setting up a plan to accommodate for the documentation gap, possibly coordinating external tests of raw materials to provide the necessary documentation.
    • The job is located in the northern part of Køge, just 20 min. drive south of Greater Copenhagen area. No travel expected. Qualifications To be successful in this role, we imagine you have:
  • A Bachelor’s degree and 1 years of relevant experience. Alternatively, 3 years of administrative experience within Documentation, Supply Chain, QA, Production Support or similar.
  • Solid GMP knowledge.
  • Experience with complex coordination and compliance and process improvement initiatives.
  • Very good communication skills with the ability to describe cases, flows and actions in a short and clear way .
  • A strong drive, a Team Player mindset and good time management skills.
  • Fluency in both written and spoken English.
    • Contact For further information or questions, please contact Helle Breinholt, Manager of Inbound Supply at +45 31 99 59 83 or [email protected]. Deadline May 30th, 2024. We encourage you 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. Working at Novo Nordisk Pharmatech Novo Nordisk Pharmatech improves biopharmaceutical manufacturing by developing and supplying innovative products used in the manufacturing of biopharmaceuticals. Biopharmaceuticals are medicines based on biological molecules, such as insulin, growth hormone and blood coagulation factors, that are purchased by Novo Nordisk and many other global pharmaceutical companies. Novo Nordisk Pharmatech improves biopharmaceutical manufacturing – and makes biopharmaceuticals cheaper to produce, thereby enabling better access to medicine for patients. In total approx. 420 employees work at Novo Nordisk Pharmatech, and even though we keep growing at a fast speed, we nurture the ‘family’ culture for instance by greeting each other and respecting each other’s unique competences and contributions, to foster a welcoming, inclusive and enabling work environment. Novo Nordisk Pharmatech is likewise unique in the way that the entire supply chain is located in one place. 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 "Produktchef", og befinder sig i kategorien "Ledelse og personale".

    Arbejdsstedet er beliggende i Køge.

    Jobbet er oprettet på vores service den 12.3.2024, men kan have været deaktiveret og genaktiveret igen.

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