Quality System Engineer – New FlexPen® Assembly Sites
Quality System Engineer – New FlexPen® Assembly Sites
Novo Nordisk A/S
Gladsaxe, 1 stilling
- Production
- Denmark - Bagsværd
Would you like to influence the way we set up our quality management system for local manufacturing sites? Are you ready for an exciting opportunity giving you the chance to work on international projects across a wide array of locations and with a broad range of stakeholders? Bring your experience into play working across our projects in IO countries like e.g. Algeria, Iran and Russia.
About the department
Local Manufacturing IO Projects (LMIOP) is part of Novo Nordisk’s Product Supply organisation. LMIOP is responsible for Novo Nordisk’s local manufacturing projects. The primary role of LMIOP is the establishment of new production sites in countries where local presence is required in order to obtain market access. These production sites are among others driven out of LMIOP’s Assembly Projects department where this job is situated. The job is located in Bagsværd, Denmark, however the projects are international and may require your presence and work locally for periods of time. Some travel activity is therefore to be expected.
The position
You will define and roll out processes within the Quality Management System across the various projects preparing for operation. You will together with QA and local organisations, being hired as we progress, define scope of the quality Management System roll out. You will define the strategy for implementing the overall changes being change and action owner driving the approach from idea to implementation. We expect you are author of the overall Validation Master Plans and SOP’s applied across the new sites. This includes training and process confirmation on site.
Understanding of cGMP is a must and validation experience is an advantage. Familiarity with project execution and project management tools is also beneficial as you will be working with a wide array of projects at different stages. We expect you to take an active role in the continuous development of the projects deliverables and work processes driven out of Assembly Projects.
Qualifications
You hold a Bachelor or Master’s degree, e.g. within Engineering or Pharmacy and have experience from medical device or pharmaceutical production. Additional experience from other areas such as quality or project management is also valued. You enjoy communicating with a diverse range of stakeholders and have a good understanding of complex processes and know how to operate in a cross-cultural organisation with a high pace. You are able to work independently and you are structured. Fluency in both written and oral English is a prerequisite.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for patients around the world. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development.
Contact
For further information, please contact Helle Hvid at +45 3079 8752.
Deadline
30 May 2016.
