Senior QA Professional for establishing new GMP production facility
In Novo Nordisk we drive our business to the benefit of patients. To be able to bring new innovative treatments to patients worldwide, we are expanding our capacities to support the company portfolio of future oral and injectable pharmaceuticals. Therefore, we are establishing a new, ground-breaking biotech API production facility in Hillerød.
In our quality organization supporting this capacity expansion, we are opening several positions as quality professionals within the following GMP production disciplines: quality assurance of design, construction and qualification of facilities and equipment used for fermentation- and purification processes. This also includes automation/IT, utilities and warehouse facilities.
The new facility is for pharmaceutical production and must be designed in accordance with cGMP requirements (current Good Manufacturing Practice).
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. Securing the quality oversight and setting the direction for implementation of cGMP. As a QA professional you will be part of a QA team reporting to a team 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.
To succeed in this role, you have:
• A Master’s degree within science or equivalent
• Extensive experience from the pharmaceutical industry
• In depth experience with GMP validation (e.g. equipment/facility qualification, IT-validation, cleaning validation etc.)
• Knowledge of GMP requirements for API production
• Strong communication skills
• Full English proficiency
On 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.
Join Novo Nordisk in times of expansion
Join us on our journey into the future and make your mark on a newly established organisation 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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