QA Professional in Chemistry, Manufacturing and Controls

1 month ago


Måløv, Denmark Novo Nordisk AS - A1p Full time

Are you eager to set direction and to ensure compliance, in close collaboration with your stakeholders? Do you thrive with various challenges and growth opportunities to handle? Do you believe in working together is better than working on your own? 

You will work with new kinds of equipment and processes and be responsible for delivering best-in-class quality for qualification of facilities and equipment. You will also have the chance to participate in project workshops and identify ways to contribute to the production facilities' compliance level, acting as a consultant for them. Apply today for a life-changing career

The position

You will be responsible for delivering best-in-class quality for qualification of facilities and equipment according to science and risk-based validation (SRV) principles. You will challenge and approve documentation, conduct QA oversight, and participate in project workshops prior to setting and approving criteria for new facilities and equipment’s.

As we support the oral development department you should expect to work with new kinds of equipment and processes. 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. Office presence expected at minimum three days weekly.

Qualifications

We seek a colleague who fits our team both professionally and personally. As a person you are open minded, have an outgoing attitude and have strong communication and collaboration skills with both your colleagues in QA and stakeholders.

You hold a MSc in Engineering, Chemistry, Pharmacy or similar You have minimum 4 years of experience within GMP and quality assurance You have experience working with qualification of facilities and equipment You understand the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity You are 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 agenda. You 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 fluentl y

The ideal candidate has experience with the SRV concept in Novo Nordisk. Further, Novo Nordisk and CMC is on a digitalization journey and experience working with IT validation will be an advantage as it will be possible to combine these skills in the job.

About the department

You will become part of a department (CMC OP Dev QA & Analysis QA) consisting of tre teams where we currently are 32 dedicated colleagues. You will be part of the CMC OP Dev QA team, reporting to the OP Dev QA manager. You will be part of a strong culture, where we strive for high psychological safety, give regular feedback, and understand that the most important thing we have is our people. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately release drug candidates for clinical trials. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk’s critical delivery of medicine to patients.


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