QA Professional for CMC

Do you value good team spirit where everyone is each other's sparring partners and respect each other's opinions and knowledge?
Do you also have a strong quality mind-set and great interpersonal skills?
Do you want to play an important role in ensuring the quality and safety of products for clinical trials?? Yes? Then this might be the right job for you. The position As a QA Professional in CMC API QA, Team Facility & Equipment, you will be responsible for delivering best-in-class quality of qualification of facilities and equipment used for GMP production of the API for clinical studies. This includes you to collaborate cross functional with scientists in the API Pilot production and your QA colleagues. Furthermore, you will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities compliance level and act as a consultant for them.

You will contribute to find solutions for ad hoc questions and challenges within cGMP compliance. In your daily work you will challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities. You will evaluate requirements and set the quality direction for the API Pilot production and projects. In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development. 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 hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar. It is expected that you have 1-3 years of experience within GMP and quality assurance. You understand how the pharmaceutical industry works. You can work with many tasks at the same time and will make decisions and follow up on quality related problems. You have an understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level. You are a self-driven and independent person with a high sense of responsibility and initiative. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders. Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better. As we operate both in a national and an international environment, you must speak and write Danish and English fluently. About the department CMC API QA is a department which employ 24 skilled and motivated colleagues, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for clinical trials. We participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future. We also have the responsibility of releasing API from contract manufacturers across the globe. We are divided into two teams and you will be part of the Facility and Equipment team consisting of 10 QA professionals. The Team is responsible for assignments at the API pilot facilities assuring the quality of the facility and the Equipment. In the department, we value teamwork, diversity, and humour very high, and we will make sure you, as our new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.
Contact For further information, please contact Associate Manager Charlotte Hellesøe Ørtoft +45 3075 1742 or Sr. QA professional Tine Harboe Wolf +45 3079 3795
Deadline 20th of February 2023. Applications will be reviewed ongoing. Interviews are held continuously, and employment can thus potentially take place before the deadline. 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. 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. 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 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.