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Qualified Person responsible of Investigational Medicinal Products

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Qualified Person responsible of Investigational Medicinal Products


Ballerup, 1 stilling

- Quality
- Denmark - Måløv

Do you see yourself contributing to maintaining the high level of quality we strive for everyday? Do you want to be part of upholding our excellent compliance level when we produce our products used for all Novo Nordisk clinical trials globally? If this is you then we have the job for you!

About the department
You will join our department which consists of 22 dedicated colleagues; we are a part of the Chemistry, Manufacturing and Control (CMC), Quality Assurance organization. Our responsibility is to ensure that all QA activities required by the GMP laws and regulations related to Investigational Medicinal Products are fulfilled. As our number of trails globally increases, so does our responsibility and we need to stay one step ahead of the development at all times.

We work with GMP at the borderline of GCP and see ourselves as key players in the success of the growing portfolio of Novo Nordisk clinical trials. In order to keep focus on this part of our quality activities we are looking to strengthen this area in our R&D organisation, with a new colleague starting 1st of August 2016.

The position
The organization continuing high level of compliance and inspection readiness is on top of your agenda. Your main focus will be split in two:

As QP delegate you will certify final packed product for use in clinical trials world-wide.

Besides this you will work with quality tasks related to preparing for labelling and packaging of Investigational Medicinal Product for trials and support the Trial Set-up department. You will approve trial specific documents and you will approve procedures, change requests and non-conformities from our internal stakeholders.

You will furthermore provide ad hoc quality support for daily operations and long term development of our business and its quality system. Here you will utilize your knowledge about Novo Nordisk plus authority regulations and requirements in order to solve our challenges.

You can look forward to entering into an energetic and positive working environment where cooperation amongst highly professional, engaged and dedicated Novo Nordisk colleagues is key to your and the company success.

Your approach to this position is a master degree as a Pharmacist or other master degree qualifying you for acting as a QP according to European legislation. The preferred candidate has experience working with development and manufacturing according to GMP requirements and has acted as a QP or QP delegate.

On a personal level, you demonstrate engagement, credibility and empowerment. You like a professional and dynamic environment with many simultaneous tasks and changing priorities. You master efficient communication, decision making and keeping cool even in tense situations - always focusing on never compromising on quality. In quality related issues you take charge and set direction to ensure timely resolution.

Working at Novo Nordisk
In Novo Nordisk it is your skills, your commitment and your ambitions, which helps us to improve many people lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.

For further information please contact Birthe Boldvig Rottwitt at +45 3075 0158.

1 June 2016.