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QA Principal Scientist in API

2 months ago

Kalundborg, Denmark Novo Nordisk AS Full time

Do you have a strong quality mindset and production understanding in a GMP regulated area? Can you optimise and simplify processes and are you eager to create continuous improvements in a dynamic organisation? Are you strong in presenting difficult issues also at inspections from authorities? Then you might be our new Principal Scientist in Active Pharmaceutical Ingredients (API) Quality Assurance (QA).
 
This is a rarely offered position with great possibilities to set your footprint on our processes, both within daily operation and projects, so apply now
 
The position
We are looking for a QA Principal Scientist with solid GMP knowledge to set direction within quality across API QA. This is the right role for you, if you have a great interest in production processes, production projects and collaboration.
 
Among your responsibilities, you will:

Support your colleagues as well as our stakeholders in the production areas.  Serve as a daily sparring partner and coach for your colleagues, and as such you must have a good overview of ongoing tasks and deliveries. Participate in production projects, ensure QA oversight. Be QA responsible for various tasks within the organisation.


In other words, it is a requirement that you will be visible in API QA, being a person that colleagues and management will rely on with your high integrity and good business understanding. You will have a broad stakeholder landscape to navigate in, both across and within the quality organisation. You will be setting scientific direction within quality assurance together with the management team, which you will be a member of.

Qualifications

You have a passion for quality and are recognized as a subject matter expert within compliance and quality assurance in pharmaceutical industry and use with ability your stakeholder interaction experience, in order to manage multiple interests and changing objectives.

To succeed in this role, you:

Hold a Master´s degree in pharmacy, engineering or natural science  Have minimum 5 years of relevant experience from the pharma industry within e.g. QA or API production Have experience and are passionate about general GMP, process optimization, problem solving in a pharmaceutical company. Have strong knowledge of QA methods, processes and regulations. Are fully proficient in English


You are attracted by the opportunity to use your deep knowledge and skills in a highly complex and ever-changing working environment. 
 
As a person, you thrive in sharing your professional insights and have the communication skills to function as a source of knowledge and a mentor for dedicated colleagues across the organisation, therefore experience with teaching and coaching will be an advantage.
 

About the department
In this position, you will be based in the QA Manufacturing II (M2) department which is responsible for assuring the quality of the API and intermediates manufactured. We perform a wide range of quality assurance activities, ranging from handling deviations, change requests, validation to quality support to optimization projects in a large CVP production area with several factories and multiple processes. We have a great collaboration with our colleagues in the production and value a high degree of flexibility and individual responsibility. The department consists of 56 highly dedicated and qualified employees divided into four teams.

The Novo Nordisk site in Kalundborg is a small city, about 60 minutes from Copenhagen and Odense. Here, thousands of colleagues work together to deliver quality products to millions of people around the world living with chronical diseases – manufacturing more than half of the entire global supply of insulin. We take pride in applying our skills and our dedication towards the mission of helping people, and we enjoy a healthy and good-spirited work environment with many opportunities for personal and professional development.