Arbejde R&D QA professional for materials used in clinical development Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse:
R&D QA professional for materials used in clinical development

jobbeskrivelse:
- Quality - Denmark - Bagsværd Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Do you want to use your profound QA knowledge, strong quality mind-set and great interpersonal skills to make a difference? If so, then this position as QA professional will give you the opportunity to be part of a team ensuring the safety of the products for clinical trials by ensuring and improving the quality of the materials used. About the department Chemistry, Manufacturing and Control Supply (CMC) is a part of the Research & Development organisation, manufacturing and distributing drug candidates for pre- and clinical trials. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. CMC Supply is organised in seven areas of expertise supporting the entire drug development pipeline. In 325 CMC API QA we are 33 colleagues in three teams. You will be part of a small dedicated team of 7, solely responsible for the quality, status assignment, and implementation of new requirements for all GMP materials in control in CMC Supply. Your high performance, quality mind-set, and good spirits will make a difference in the daily lives of your colleagues, stakeholders and, by ensuring the quality of the materials used, also in the lives of the many people participating in the clinical trials at Novo Nordisk A/S. The job As a QA professional, you will be responsible for delivering best-in-class quality of materials and excipients used in GMP production of API and drug product for clinical studies in phase 1, 2 and 3. You will collaborate with stakeholders in different departments with many different areas of expertise such as scientists in the pilot production, sourcing professionals and of cause QA colleagues. In your daily work you will be challenging and approving supply chain evaluations, specifications, suitability evaluations and other supporting documents produced by your stakeholders. You will be in contact with your stakeholders about the introduction, implementation and evaluation of the materials used. You will evaluate the need for audits with external suppliers and participate in the audits. You will also evaluate the requirement for and negotiate quality agreements with external suppliers. In our team, we are continuously improving the quality of the materials in control in CMC Supply, we are constantly optimizing our methods and processes as part of a LEAN culture. We make a difference in 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. Qualifications You have a Master’s degree in Science, Pharmaceutical Sciences, Engineering or similar qualifications. You have at least two years’ experience with GMP and a strong quality mind-set. You are ambitious and determined on creating world-class results and ensure the highest quality of the materials in control. You have experience working in a LEAN environment and enjoy working in a team where we are constantly improving our methods and processes.You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. You have good interpersonal skills and you keep your spirits high even under pressure. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please call Rebekka

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark

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