QA Professional for CMC API - QP delegate

Novo Nordisk A/S

Fuldtidsjob
Storkøbenhavn

Category:

Quality

Location:

Bagsværd, Capital Region of Denmark, DK

Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, this position as QA Professional can be a unique possibility for you.

As part of Novo Nordisk’s R&D family, CMC Development makes a difference for patients with chronic diseases across the world and the organisation develop, manufacture and distribute drug candidates for non-clinical and clinical trials.

CMC Development and CMC QA is an ambitious organisation with a strong culture, that always seek to solve problems, have an eye for the entire business and do our best to deliver despite any obstacles along the way. We have a high focus on delivering high quality to our customers which is why we are looking for a QA Professional to take an active part in securing our quality level.

About the department
CMC API QA has a mission to assure that each and every Active Pharmaceutical Ingredient (API) activity in our development projects live up to the cGMP requirements for the safety of our patients. We are 25 colleagues divided into two teams. You will be part of a dedicated team of 10 highly qualified technicians and professionals who ensures status assignment of products and qualification of facilities and equipment in Upstream Facilities in CMC API.

The job

In this role, you will be responsible for delivering best-in-class quality assurance

of our new manufacturing processes and API for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability and status assignment of API for clinical trials and release of raw materials for production in CMC.

In addition, you will be a part of our development projects ensuring our products used in clinical trials are following the information provided to Health Authorities worldwide. 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.

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

You hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar. In addition, you have

+3 years of experience with GMP and quality assurance – preferably within batch release/status assignment. Furthermore, you understand how the pharmaceutical industry works. You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity.

You are a self-driven and independent person with a high sense of responsibility and initiative, and you can work with many tasks at the same time. In addition, you are ready to make decisions and follow up on quality related problems. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders.

The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level.

As we operate both in a national and an international environment, you must speak and write Danish and English fluently.

Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Contact
For further information, please contact Charlotte Hellesøe Ørtoft at +45 3075 1742.

Deadline
24 January 2020.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


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Fuldtidsjob
Storkøbenhavn
Kemi, Biotek & Materialer
Medicinal & Sundhed
Produktion, Logistik & Transport
Teknik & Teknologi
Data & analyse
Forskning & Udvikling
Medicinal & Sundhed
Naturvidenskab
Produktion
Teknik



Novo Nordisk A/S - hurtigt overblik


Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

Placering
Novo Allé
2880 Bagsværd
Logo: Novo Nordisk A/S
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https://jobbank.dk/job/1451080/