Senior QA Professional for establishing new API production facility
2 weeks ago
Join Novo Nordisk as we pave the way for patient-centric innovation. We're expanding our capabilities to deliver groundbreaking pharmaceuticals globally, and we're proud to announce the establishment of a cutting-edge biotech API production facility in Hillerød.
Are you passionate about ensuring the quality assurance of facility design, construction, and equipment qualification for cutting-edge pharmaceutical production? Ready to showcase your expertise in maintaining impeccable quality standards throughout the construction phase of our groundbreaking biotech API production facility?
This new facility sets the standard for pharmaceutical production, adhering strictly to cGMP requirements (current Good Manufacturing Practice).
If you're ready to make a difference in the lives of patients worldwide, join us in shaping the future of healthcare as the next Senior Quality Professional
The position
You will be part of a highly skilled QA team allocated to perform quality assurance activities during design and construction of the new API production facility in Hillerød. The QA team will support the project throughout the project phases and after completion of the facility. Your primary task will be to secure the quality oversight and setting the direction for implementation of cGMP. As a QA professional you will be part of a QA department reporting to a senior manager.
Knowledge of facility/equipment qualification, knowledge of general cGMP requirements and the ability to perform quality oversight according to GMP are essential skills in the job. You should be able to communicate and explain the intent of the GMP requirements for the project team members and relevant project stakeholders.
Qualifications
To succeed in this role, you have:
A Master’s degree within science or equivalent Experience from the pharmaceutical industry Knowledge of GMP validation (e.g. equipment/facility qualification, cleaning validation etc.) Expertise of Downstream processes Proficiency in GMP requirements for API production Communication skills Full English proficiencyOn a personal level, you enjoy close teamwork, are a strong motivator of others and can stay balanced, when the waves get high. You thrive in a multicultural environment working across organizational borders and management levels. Building structures comes naturally to you and you enjoy simplifying wherever simplicity can benefit reaching the goals fast and in a sound and solid manner.
About the department
API Expansions QA 25L is a department with a total of 10 employees and growing. The department’s responsibility is to ensure involvement in the production facility investment projects, in order to ensure compliance, timely approval and the foundation for flawless operation of our new facilities.
Join Novo Nordisk in times of expansion
Join us on our journey into the future and make your mark on a newly established organization that will be growing in the coming years.
Join us if you would like to work with dedicated and experienced QAs professionals, if you are curious about the opportunity to establish a factory that bridges new and automated technologies with strong know-how and expertise in biotech manufacturing; and if you are interested in starting up the new facility and when built become part of the team supporting production of the new products.
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