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Quality Assurance Professional for Validation and Qualification

Category:  Quality
Location: 

Kalundborg, Region Zealand, DK

 

 

 

Would you like to be a part of an excellent team and be responsible for building up and maintaining working procedures or systems to assure cGMP compliance? Then our newly opened Quality Assurance Professional for Biopharm Finished Products role might be something for you!

 

 

The position

 

As QA Professional you will have broad contacts to our production. Our main responsibility is to set direction for quality and compliance, due to internal and external requirements. We are offering an exciting and challenging job, where you will become a part of a competent and solution-oriented team, working as sparring and problem solvers regarding quality issues in the production.

 

In this role your main responsibilities will be:

 

  • Review and approve validation and qualification documentation.
  • Set direction regarding qualification requirements in ongoing and new projects.
  • Perform Quality Assurance in different Biopharm departments.
  • Perform Quality Assurance tasks (i.e. case handling of all sorts of documents regarding NN QMS).
  • Provide professional sparring and guidance to team members in complex cases.
  • Perform QA Oversight.
  • Contribute to building up and maintaining working procedures and systems to assure cGMP compliance.

 

In this job you will get a real opportunity to make an impact with your decisions, initiatives and engagement.

 

Qualifications

 

To be successful in this role we expect you to have:

 

  • Master’s degree (preferably: Pharmacy, Veterinarian, Microbiology, Engineering – but another educational background will also be considered).
  • Preferably 5-10 years of experience in QA or 2-3 years of experience in Novo Nordisk QA environment.
  • Validation experience will be an advantage.
  • Good command of English and Danish.
  • High quality mindset.
  • Good analytical skills.

 

On a personal level you need to be communicative and outgoing, able to build strong relations to ensure solid cooperation across the departments. You are a dedicated and engaged person, capable to work independently, with proactive and self-driven approach. A positive attitude is an absolute necessity.

 

About the department

 

Biopharm Quality Assurance Finished Products Kalundborg, is a department in a rapid development. We are QA for Biopharm’s aseptic factory and packaging department which is producing haemophilia products, growth hormone and glucagon with more products to be added. It is us who set the direction for quality of products in development and production to market and we ensure that the production always follows all requirements and regulations. 

 

The department has a very good cooperation both internally and with the rest of Biopharm QA as well as with production and stakeholders. We are engaged in our jobs, have a lot of positive attitude and an open and honest communication.

 

Working at Novo Nordisk

 

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.

 

Contact


If you would like to know more, please contact Kenneth Weiersøe Højer at +45 30 79 54 88.

 

Deadline

 

5th October 2021.

 

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. 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. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.