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Quality Assurance Specialist

3 weeks ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team in Kalundborg, Denmark.

As a key member of our Aseptic Manufacturing Quality Assurance department, you will play a crucial role in ensuring the highest standards of quality and compliance in our production processes.

Main Responsibilities:

  • To review batch documentation, trend reports, Standard Operating Procedures (SOPs), and deviations to ensure adherence to current rules and guidelines.
  • To observe performed processes and help solve issues in real-time.
  • Quality Assurance oversight during aseptic filling.
  • To advise stakeholders on ensuring the right level of quality in production processes.
  • Participating and presenting cases when inspected by authorities.
  • Improving processes in your working area.

Requirements:

  • A Master's degree in pharmacy, medicine, microbiology, veterinary medicine, or similar field.
  • One year+ of experience within QA or other relevant production-related job would be advantageous.
  • Knowledge of Good Manufacturing Practice (GMP) and regulations.
  • Strong communication skills with stakeholders, maintaining a respectful tone.
  • Proficiency in Danish and English, along with good IT skills.

About Our Team

We are a well-functioning department with many interfaces in the organization, including production, management, and other QA departments. We have 60 engaged employees with a great team spirit and open honest communication.