- You hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar.
- You have 2-3 years of experience within GMP, quality assurance and the pharmaceutical industry.
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QA Professional, Team Facility and Equipment - Bagsværd, Danmark - Novo Nordisk
Beskrivelse
The positionAs a QA Professional in CMC API QA, you will be responsible for delivering best-in-class quality assurance of qualification of facilities and equipment used for GMP production of the API for clinical studies.
This includes you to collaborate cross functional with scientists in the API Pilot production and your QA colleagues.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.
You will contribute to find solutions for ad hoc questions and challenges within cGMP compliance.In your daily work you will challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities.
You will evaluate requirements and set the quality direction for the API Pilot production and projects.In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development.
We make a difference in the lives of people participating in clinical trials in Novo Nordisk A/S, by ensuring that the products they receive are safe, of the highest quality and produced in compliance with legislation.
Qualifications To be successful in this role, we are looking for someone with the following qualifications:Soft skills:
You are a 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 the agenda, and like working with many different stakeholders.
Further, it is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better.
On a personal level, you are ambitious, curious, proactive and have a strong interest in developing yourself and people in your network.
You demonstrate a service-minded attitude, independence, a focus on simplicity and a sense of responsibility for your tasks. Finally, you exhibit excellent communication skills, enabling effective collaboration with individuals from diverse nationalities and cultures.About the department CMC API QA is a department which employ 36 skilled and motivated colleagues, all based in Bagsværd.
We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for clinical trials.
We participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future.
We also have the responsibility of releasing API from contract manufacturers across the globe.We are divided into 3 teams and you will be part of the Facility and Equipment team consisting of 13 QA professionals.
The Team is responsible for assignments at the API pilot facilities assuring the quality of the facility and the Equipment.
In the department, we value teamwork, diversity and humour very high, and we will make sure you, as our new employee, feel welcome and integrated.
Further, a thorough individual training plan will be made together with your mentor. Working at Novo Nordisk At Novo Nordisk, we don't wait for change. We drive it.We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.