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QA Specialist for Validation

1 month ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Jobbeskrivelse
Placering
Bagsværd, Denmark

Jobkategori
Quality

Ansøg nu

Would you like to play an important role in ensuring the quality and safety of products for clinical trials, where you can use your solid QA and validation experience in a project context? Then we can offer you a unique position with a lot of responsibility and impact in a dynamic and highly professional environment, read more and apply now

The position
Chemistry, Manufacturing and Control, Active Pharmaceutical Ingredients (CMC API) QA is looking for a QA Validation Specialist to be part of an optimization project that is already running at full speed. In the position, you will refer to the QA Director.

CMC API Pilot facilities are expanding their production capacity for clinical trials phase 3. We are looking for a Validation Specialist to be part of a team of 10 dedicated and highly skilled Project QAs allocated for this project.

In this role, you will – together with our other QA Validation Specialist - be responsible for:

  1. Setting the quality direction for the capacity expansion project
  2. Deliver best-in-class quality for qualification of equipment/facilities and IT-systems
  3. Handle larger and complex quality issues
  4. Ensure a LEAN culture and drive improvement activities across areas
  5. Represent CMC QA in cross-organisational groups in Novo Nordisk

Moreover, you will be leveraging knowledge of quality assurance to strengthen the QA competences in the department through training and sparring within your own area of expertise.

Qualifications
In this dynamic team, a high level of innovation to deal with new situations is expected, which will help you with solving complex problems and taking a new perspective using existing solutions.

To succeed in this role, you:

  1. Hold a Master in Pharmacy, Engineering, Biology, Biotechnology, Chemistry or similar
  2. Have at least 7 years of experience in QA roles in the pharmaceutical industry
  3. Ideally have experience within validation of GMP facilities and equipment
  4. Have a flair for IT
  5. Are fully proficient in English

On a personal level, you show excellent interpersonal skills, with the ability to clearly and precisely communicate complex matters to stakeholders; this will help you when providing professional direction with scientific sparring partner to management.

You think above and beyond your own area and improve our processes based on value chain understanding, leading the way and taking co-responsibility for employee development by knowledge sharing and valuable feedback.

Finally, you are self-driven and independent with a high sense of responsibility and initiative, and you thrive in a dynamic environment, where teamwork is on the top of the agenda and you like working with many different stakeholders.

About the department
CMC API QA is a department which employs over 40 skilled and motivated colleagues divided into 4 teams all based in Site Bagsværd. We work with assuring quality and compliance of the CMC API facilities & equipment and release of raw materials, cell banks and API for clinical trials. We participate as QA for smaller or bigger investment projects to make our API Pilot facilities prepared for the future.

Our department values teamwork, diversity, and humour and we will make sure that you, as our new employee, feel welcome and included. A thorough individual training plan will be made for you 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.

Contact
For further information, please contact Director Rikke Wissing Jensen +45 3075 1566 or QA Specialist Rune Munk Pedersen +45 3079 8106.

Deadline
20 September 2024. Applications will be reviewed ongoing. Interviews are held continuously, and employment can thus potentially take place before the deadline.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. Together, we're life-changing.

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