QA Professional

Wanted: Keen QA Professional
Are you good to perceive and familiarize yourself with new issues in a hurry? Do you keep an overview under pressure? Can you differ between necessary and sufficient? Do you want to work in a highly committed environment with highly competent and experienced colleagues? Are you motivated by taking responsibility for setting direction and ensuring quality in a production that produces and develops at a high pace?
Then we might be your new colleagues 😊 The Position
As our new QA Professional, you will help ensure the quality of IM1 at Novo Nordisk in Kalundborg and get to cooperate closely with the production departments. Our team works primarily with the departments for Purification, Environmental Monitoring, IT and for the execution of projects. You will be handling one or more of these areas, depending on your wishes and competencies. We focus on patient safety in the interpretation, dissemination and implementation of regulatory requirements, compliance signals and local requirements in all relevant tasks and documents. The position requires a high degree of independence as well as strong communication and collaboration skills.
Our work tasks are versatile, most of our time is spent sparring and setting the direction for quality, we approve, among other things, documents from stakeholders (deviations, change requests, batch, trend and validation / qualification reports). Our Qualified Person delegates are responsible for ensuring that the products leaving IM1 are ready for our patients in terms of quality. We prepare Annual Product and Specifications Reviews. We participate in cross-cutting process group work. We are on go-look-see in connection with systematic problem solving, and we exercise QA presence on running production to ensure continuous improvements and prevent future errors. Qualifications
We are looking for a keen colleague with good collaborations skills who can work both independently and in teams.
You are proactive and passionate about your tasks. You meet your deadlines, take visible responsibility in relation to your areas of responsibility, and with your structured approach to your tasks, you maintain an overview - even in a changeable and busy environment where priorities can change quickly. You embrace changes and are happy to challenge our way of working so that we become even better.
You have a good sense of humor and you contribute with your open and productive attitude to a good work environment.
You imagine you have:
• A master’s degree in pharmacy, engineering, biology or equivalent.
• If you can fulfil the requirements to become a “Qualified Person” (QP), according to The Danish Medicines Agency certification, it will be an advantage.
• Fluent in Danish and English – oral and written.
• It will be an advantage (but not a requirement) with production, project or QA experience from the pharmaceutical industry About the department
Our department consists of a staff team as well as three QA teams. Our team 351.02 consists of 16 QA professionals and an associate manager.
We support IM1, still the largest API factory in Denmark. There are more than 600 employees here and we are responsible for producing several of Novo Nordisk's newest and most coveted active substances. Our ambition is to be a competent, solution-oriented, and experienced sparring partner for our stakeholders in production, so that our common goal of ensuring the quality of our patients is met. We can offer you an exciting and challenging job with committed colleagues in a changing environment. A well-functioning team, where we focus on internal sparring, alignment, and work / life balance. We can offer involvement in projects, if/when you have the competencies needed. We know that you will develop both your professional and personal competencies, and that you will contribute to the next stage of Novo Nordisk's success story. More than 90 years of innovation and leadership have placed us in world-class within e.g., diabetes, and we are constantly working to maintain and expand our position so that even more people can access our life-changing products.
Working in Novo Nordisk
Novo Nordisk in Kalundborg is a city within the city, located just an hour's drive from Copenhagen. The area covers over 1,350,000 m2 and have its own road network. We are approx. 3000 employees in 16 factories, and we produce approximately 50% of the world's insulin. We are at the forefront of developments in technology, systems, methods, and processes. 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.
Contact
For further information, please contact associate manager Jannie Gregers, Phone +45 30792413 between 10 am and 2 pm. Application deadline
15 October 2023
Please be advised that interviews will be conducted on an ongoing basis, so 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.
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.