Experienced QA Professional

Category:  Quality
Location: 

Bagsværd, Capital Region of Denmark, DK

   

Are you an experienced QA Professional with solid experience, who is eager to set direction and to ensure compliance, in close work with your stakeholders? Do you thrive in a constantly changing environment with various challenges and growth opportunities to handle? Then you have a great opportunity to be our new QA Professional.

 

The position

As QA Professional in QA for QC you will be the QA for the analytical and microbial QC laboratories and competence centres in Insulin Finished Products Manufacturing Development (IFP Man Dev). In this position you will contribute to ensure a high level of quality set the quality direction for QC processes and activities performed in IFP.

 

Typical tasks will be sparring with stakeholders on quality matters, reviewing and approving documentation e.g., Deviations, Laboratory Investigations, Change Requests, SOPs. Furthermore, approval of equipment qualification and approval of validation of analytical or microbial methods will be an area of responsibility.

Participation in projects within core competencies is also an opportunity.

 

Qualifications

  • Pharmacy or corresponding education (for example BSc/MSc. Chem Eng. or MSc. Biology)
  • Have at least 3 years’ experience from a pharmaceutical organization, within quality assurance or quality control.
  • Ideally you have solid knowledge within validation of analytical methods, equipment qualification or microbial analysis.
  • It will be an advantage if you have experience working with contract manufacturing organizations (CMO) and interest within digitalization, automation, and process analytical technologies

 

Soft skills

  • You are open and inclusive in relation to your colleagues and stakeholders and demonstrate a high level of responsibility
  • You can communicate clearly and effectively with in a respectful manner. We are cooperating broadly with many stakeholders and therefore excellent collaboration and communication will be crucial for your success
  • You can demonstrate solution-focused dialogue with both stakeholders and your other QA colleagues

 

About the department

The department is QA for Injectable Finished Product Manufacturing Development (ManDev). ManDev is the link between R&D and manufacturing sites and drive upscaling, improvements, product and process support, and development of new chemical and microbial analytical methods. ManDev is the the compliance partner and manage cross-organisational compliance project. Furthermore, the responsibility for the Danish QC laboratories in Bagsværd and Hillerød along with support to other global QC laboratories lies within ManDev’s responsibility.

You will be a part of the QA for QC team which covers analytical and microbial Competence Centres and QC laboratories located in Bagsværd and Hillerød.

The team consist of 11 QA colleagues who take pride in their work and value a good working environment. We are situated in Bagsværd, Denmark.

The department consist of ca. 40 employees and support various functions in IFP Man Dev.

 

Contact

For further information, please contact Associate Manager Christoffer Bjarrum Winther +45-30752285.

 

Deadline

Deadline to apply for this position is October 8th, 2023.

Applications will be evaluated continuously, when received and candidates may be called for interview before the deadline.

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.

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 communities we operate in. Together, we’re life changing.