Novo Nordisk
Qualified Person Delegate - QPD
Are you a Qualified Persons Delegate (QPD) seeking a rewarding career opportunity in the pharmaceutical industry? Look no further!
We're embarking on an exciting expansion at Novo Nordisk Global Contract Manufacturing (GCM) QA and are on the hunt for talented QPDs to join our growing team. As a key player in ensuring regulatory compliance and product quality, you'll have the chance to make a real impact on our company's success.
If you're passionate about upholding the highest standards of pharmaceutical manufacturing and eager to be part of a collaborative and innovative environment, we want to hear from you! Take the next step in your career with us and be a part of something extraordinary. Apply now!
Please note that this position is placed at our offices in Søborg. However, we are moving to new offices in Høje Taastrup – expected moving date is February 2025.
The position
As QA professional or QPD you will play a crucial role in ensuring the safety, efficacy, and compliance of our contract manufacturing for drug product Contract Manufacturing Organizations (CMOs) in our QA Aseptic (AP) Operation team. Responsibilities encompass a range of tasks aimed at maintaining high-quality standards for our CMOs.
Main tasks will be to:
ensure that all manufacturing activities adhere to relevant regulations and guidelines set forth by regulatory authorities
review batch records and final release of batch from the CMOs
set direction and guidance for improve and maintain robust Quality Management Systems to monitor and continuously improve manufacturing processes
document approval of deviation, change control, and CAPAs to address any issues that may arise during production
having daily interactions with both internal and external business partners, and while you can expect a high level of complexity in your tasks.
The daily QA activities are typically carried out by the contract manufacturers themselves, but the handling of documentation from the contract manufacturers is part of your job.
This role will provide you with a wide variety of challenges and opportunities for growth.
Overall, you will play a critical role in safeguarding patient safety and maintaining the integrity of our pharmaceutical products.
Since the manufacturers are located outside Denmark, you are expected to travel 5-15 days a year.
Qualifications
Candidates interested in applying for the QPD role should be aware that the eligibility criteria are stringent and are determined by the Danish Medicines Agency. Therefore, we encourage you to carefully review the specific requirements outlined by the agency here before submitting your application.
To succeed in this role, you:
hold master’s degree in pharmacy, Medicine, Veterinary Medicine, Pharmaceutical chemistry and technology, Chemistry or Biology
have at least 1 year of experience in a QA related or Process Supporter role
have gained said experience within the pharmaceutical or medical devices industry
are fully proficient in English, while Danish knowledge will be seen as an advantage
On a personal level, with your good cooperation and communication skills you are able to organize and drive tasks working across departments in an international organization. You have a pragmatic approach to problem solving, are detail-oriented with a strong quality mindset and are a team player but are also able to work independently.
About the department
GCM QA DP is a dynamic department consisting of 65 competent people and is characterised by a high level of professionalism, flexibility and cooperation. Our department is responsible for quality assurance and quality support for outsourced production activities worldwide, as well as setting direction for our Global Contract Manufacturer Organisations worldwide.
The open position as QP Delegate is in the GCM QA DP Operations AP teams. GCM QA DP Operations AP is responsible for aseptic products produced at the CMOs, while GCM QA DP.
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