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CVP Quality Coordinator

Category:  Manufacturing
Location: 

Kalundborg, Region Zealand, DK

   

CVP Quality Coordinator to Analytical Support & Process Support in Manufacturing Development (MDev) for Diabetes API’s

 

Are you looking for new challenges? Would you like to have an impact on how two departments / area are in control with regards to quality and GMP? Then you may be the quality minded and independent CVP Quality Coordinator we need in the analytical support laboratory & process support

 

About the departments Analytical Support is situated in Kalundborg and is responsible for the late phase development and validation of “new product” analytical methods, prior to transfer to QC departments. The department also provides analysis support to optimization projects in Novo Nordisk's Diabetes Active Pharmaceutical Ingredient (DAPI) production. Lastly the department plays a crucial role in supporting the production and the quality control laboratories. We are 65 committed employees divided into four teams. Process Support is situated in Bagsværd and is responsible for providing support to all DAPI production areas, including lab. scale experiments, optimisations and problem solving. The department perform and reports stability studies for all marketed and phase III products as well. For new products the department provide documentation and support from phase III to New Drug Application. We are 75 committed employees divided in 5 teams.

 

The job

You will work in Kalundborg 4 days a week and 1 day a week in Bagsværd supporting and coordinating quality & GMP activities across the two departments. As CVP quality coordinator you are responsible for preparing and coordinating all internal audits and external inspections in DAPI MDev (6 departments) and preparing the Quality Management Review (QMR) for DAPI MDev. Many automation and digitalisation initiatives are being driven in the two departments and the CVP quality coordinator is responsible for challenging and sparring with the owners of these initiatives ensuring the right quality management system – that reflects the balance between development and production.  

 

Qualifications You must have a master’s degree within engineering, chemistry or another relevant MSc.  

 

To succeed in the role, we expect that you have a deep understanding of GMP and Quality in production and analytical laboratories from years of relevant experience in the Pharma industry You have a strong analytical mindset, holistic perspective on business processes and ability to see what is important, and what is not.  

 

On the personal level we expect you to be committed and show a high level of independence. We also expect that you are good at creating a clear overview and prioritising your tasks. You never compromise on quality and are also good at completing your tasks on time, then moving on to the next task with enthusiasm and energy. You have excellent communication skills and feel comfortable collaborating with people at all levels.  

 

All in all, we offer a very exciting job, with good development opportunities for the right candidate.

 

Novo Nordisk in Kalundborg

Novo Nordisk in Kalundborg is the world's largest insulin production site - big enough to have a 5.5 km run around the site and to produce half of the insulin used worldwide. This is a workplace for more than 2,800 dedicated Novo Nordisk employees who set ambitious goals and strive to make a difference for our more than 24 million patients through stable deliveries of high-quality products. The site is in rapid development with lots of exciting challenges. We solve them by being at the forefront of technology, systems, methods and processes, and by assembling teams of talented employees.  

 

In Novo Nordisk it is your ability, your commitment and your ambitions which help us improve the lives of many people. On the other hand, we offer you the opportunity to work with talented colleagues and we offer you a wide range of opportunities for professional and personal development.

 

Contact

Do you have any questions regarding the position or want to know more? Feel free to contact Marina Bryld on +45 3075 7338

 

Deadline

5th October 2021

 

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.