Qualified Person Delegate - Bagsværd, Danmark - Novo Nordisk

Beskrivelse

The position

As QA professional or QPD you will play a crucial role in ensuring the safety, efficacy, and compliance of pharmaceutical products.

Responsibilities encompass a range of tasks aimed at maintaining high-quality standards throughout the manufacturing process.


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 release of each batch of pharmaceutical products for distribution 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 identify potential issues within the manufacturing process and implement mitigation strategies to minimize the likelihood of non-compliance This role will allow you to collaborate with cross-functional teams to address any findings and implement corrective actions to drive continuous improvement.

Overall, you will play a critical role in safeguarding patient safety and maintaining the integrity of pharmaceutical products. The successful candidates will be employed at either Taastrup or Måløv.

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 masters' 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 As this is an expansive hiring initiative across multiple departments, we want to emphasize to potential candidates that while we are eager to welcome diverse talent to our team, specific skill sets may be assessed at later stages in the recruitment process.

As the selection process progresses, we will delve deeper into specific skill requirements for each department, ensuring the best possible alignment between candidate expertise and role expectations.

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 The area is newly established to support a revised Novo Nordisk Strategy, where used of acquisitions, partnership and contract manufacturing will play a key role in supplementing the future organic growth.

The Corporate Vice President (VP) area consists of four VP areas: Due diligence and Integration Quality, responsible for quality related matters around business development; ET QA who is responsible for Quality of tablet production and manufacturing with emerging technologies and GCM DS QA and GCM DP QA, responsible for Quality Assurance of Global Contract Manufacturing.

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.