Advanced QA and QP Delegate for Clinical development batches

at  Novo Nordisk

Advanced QA and QP Delegate for Clinical development batches
Category: Quality
Location:Måløv, Capital Region of Denmark, DK
Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, then this position as QA Professional/QP delegate can be an exciting possibility for you as we are expanding.
CMC Development makes a difference for patients with chronic diseases across the world and the organisation develop, manufacture, and distribute drug candidates for clinical trials.
CMC Development/CMC QA is an ambitious organisation with a strong culture, that always seek to solve problems, have an eye for the entire business and do the best to deliver despite any obstacles along the way. We have a high focus on delivering high quality to our customers which is why we are looking for a dedicated and experienced QA to take an active part in securing our quality level.

QUALIFICATIONS

You hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar and fulfil the requirements from the Danish Health Authorities to become QP delegate. You have experience with GMP and quality assurance - preferably within batch release/status assignment. Experience with activities in (aseptic) production and/or QC is an advantage.
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, make decisions and follow-up on quality related problems.
You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity.
You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders.
As we operate both in a national and an international environment, you must speak and write Danish and English fluently or are in the process of taking Danish courses on a high level.

Please refer the Job description for details