QA Professional, Team Facility and Equipment

Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? Are you skilled in navigating complex stakeholder landscapes and do you believe in working together is better than working on your own? 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. 

If this sounds like you, then this might be the right job for you!

The position 

As a QA Professional in CMC API QA, you will be responsible for delivering best-in-class quality assurance 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 
To be successful in this role, we are looking for someone with the following qualifications:
• You hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar. 
• You have 2-3 years of experience within GMP, quality assurance and the pharmaceutical industry. 
• It is an advantage if you speak and write Danish and English fluently as we operate both in a national and an international environment.

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. 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.

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.

Soft skills:
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. 

On a personal level, you are ambitious, curious, proactive and have a strong interest in developing yourself and people in your network. You demonstrate a service-minded attitude, independence, a focus on simplicity and a sense of responsibility for your tasks. Finally, you exhibit excellent communication skills, enabling effective collaboration with individuals from diverse nationalities and cultures. 

About the department 

CMC API QA is a department which employ 36 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 3 teams and you will be part of the Facility and Equipment team consisting of 13 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.