QA Specialist

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Would you like to be a part of a QA organisation that sets quality direction and ensure that microbial analysis methods and processes used in Novo Nordisk meet regulatory requirements? Are you known for your drive and willingness to make decisions that balance the highest quality and business needs? If yes, it’s the most perfect time to join our company and be part of a life-changing career! The position As QA for Manufacturing Development, you won't just be a part of the team - you'll be a driving force in ensuring that microbial analysis methods and processes used across Novo Nordisk, Injectable Finished Product are compliant and live up to regulatory requirements. With a chance to influence and set the direction for these elements, you'll have the opportunity to make a significant impact on our company's success. Your main responsibilities will be to:
  • Be the lead voice in setting quality direction within Novo Nordisk’s microbial processes and support implementation of new compliance signals from regulatory authorities.
  • Get involved in critical and complex situations and will be the driver in solving them
  • Be a sparring partner across the organization within quality
  • Act as coach/mentor to develop you colleagues professionally within your field
    • Furthermore, you will provide support to projects related to core area of expertise. Qualifications We are looking for someone who can lead and extensively analyse critical situations that might lead to serious quality defects. You are known for your drive and willingness to make decisions that balance quality, demands, authority expectations, and business needs. To succeed in this role, you:
  • Hold a master’s degree or preferable a PhD in Microbiology, Biology, Pharmaceutical science or equivalent
  • Have extensive knowledge and at least 7 years of experience within microbiological methodology and analysis from pharmaceutical industry
  • Preferably have knowledge within aseptic production processes and environmental monitoring
  • Knowledge of what it requires to comply with Good Manufacturing Practice
  • Are fluent in English
    • As a person,you are a resourceful person and show a high level of responsibility and knows how to set things in perspective and see the big picture. You thrive in a dynamic environment with collaboration with many different stakeholders and can communicate clearly and effectively in a respectful manner. You are open, honest, forthcoming, and inclusive in relation to your colleagues and stakeholders, acting as an ambassador for the team and department. About the department The department is QA for Injectable Finished Product Manufacturing Development (ManDev). ManDev is the link between R&D and manufacturing sites and drive upscaling, improvements, product and process support, and development of new chemical and microbial analytical methods. We are the compliance partner and manage cross-organisational compliance project. Furthermore, the responsibility for the Danish QC laboratories in Bagsværd and Hillerød along with support to other global QC laboratories lies within ManDev’s responsibility. You will be a part of the QA for QC team which covers analytical and microbial QC laboratories and Competence Centres located in Bagsværd and Hillerød. The team consist of 11 QA colleagues who take pride in their work and value a good working environment. We are situated in Bagsværd, Denmark. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information about the role, please contact Associate Manager Christoffer Bjarrum Winther at +45-30752285 Deadline 3 November 2023 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.


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

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 7.9.2023, men kan have været deaktiveret og genaktiveret igen.

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