Analysis QA in CMC
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Måløv
Are you ready to ensure compliance and high quality in development laboratories and analytical project activities? Would you thrive by working with skilled colleagues known for their fantastic team spirit? Then, come working with us in Måløv. The position In close cooperation with colleagues, you will act as QA for our analytical development departments. Your main responsibility will be to quality assure the laboratories. Thereby contribute to the products are of high standards and in full compliance with the current rules and guidelines. You will approve method qualification and validation documentation from Chemistry, Manufacturing and Control (CMC) analytical departments and contract manufactures (CMOs) in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials. You will work and be consulted in various development projects on analytical topics and be expected to have a risk-based approach to the development process and product. In connection to this you find the right balance between patient safety, compliance to requirements and effective business conduct. In addition, the job also includes approval of qualification and validation documentation for laboratory equipment. Qualifications You hold an academic degree as pharmacist, veterinary medicine, engineer or similar Have at least 3 years’ experience from a pharmaceutical organisation, preferable within quality assurance or quality control, where you have gained a solid and up-to-date knowledge of quality and Good Manufacturing Practise (GMP) requirements. Ideally solid knowledge within validation of analytical methods and equipment qualification You contribute positively to our team and enjoy working with people from different professional backgrounds who are dedicated towards our common goal You are eager to see things moving forward in a dynamic environment where projects and processes vary, which demands the need for flexibility and skills to organise and drive tasks. Thus, making an impact with your ideas and suggestions You take a pragmatic approach to problem solving and have a strong quality mind set Good communication skills are a must, and you can communicate complex content to people with different backgrounds and skills Fluent in Danish and English is a must As person you are open-minded with an outgoing attitude and natural networking skills. Additionally, we would enjoy having a straightforward person with a good sense of humour in our department. About the team We are a well-functional and a very harmonious social team. Novo Nordisk is going into digital improvements and seeking a new colleague to help us support this transition. We are 8 dedicated colleagues ensuring that the laboratories and their analysis activities for all Novo Nordisk development projects live up to cGMP requirements.
We continuing to make sure that high level of audit and inspection readiness is on top on our agenda. Therefore, we work with QA oversight where we proactively will identify areas where compliance can be strengthened, and we can work smarter with digital solutions and automated processes. You will develop a broad knowledge of all analytical methods involved in testing clinical products and you will work in close collaboration with main stakeholder departments to identify opportunities for optimizations and simplifications. 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 further information, please contact Senior QA Professional Mette Strid +45 3079 0651 Deadline
25 september, 2023 You may submit your application in English or in Danish. 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. 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.
We continuing to make sure that high level of audit and inspection readiness is on top on our agenda. Therefore, we work with QA oversight where we proactively will identify areas where compliance can be strengthened, and we can work smarter with digital solutions and automated processes. You will develop a broad knowledge of all analytical methods involved in testing clinical products and you will work in close collaboration with main stakeholder departments to identify opportunities for optimizations and simplifications. 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 further information, please contact Senior QA Professional Mette Strid +45 3079 0651 Deadline
25 september, 2023 You may submit your application in English or in Danish. 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. 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 Måløv.
Jobbet er oprettet på vores service den 1.6.2023, 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
- Måløv
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