Quality Assurance Specialist

6 days ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time
About Us

Novo Nordisk A/S is a leading global healthcare company with a rich 100-year legacy of driving change to defeat serious chronic diseases. We are committed to creating an inclusive culture that celebrates the diversity of our employees, patients we serve, and communities we operate in.

The Role

We are seeking a skilled Quality Assurance Specialist to join our Aseptic Manufacturing team in Kalundborg. As a member of this team, you will play a critical role in ensuring the high standards of our products and compliance with current rules and guidelines.

Responsibilities
  1. Review batch documentation, trend reports, Standard Operating Procedures (SOPs), and deviations to ensure quality standards are met.
  2. Provide real-time issue resolution support during operational processes.
  3. Offer Quality Assurance oversight during aseptic filling operations.
  4. Collaborate with stakeholders to ensure the appropriate level of quality in production processes.
  5. Take part in international regulatory inspections and improve local processes.
Requirements
  • Masters degree in pharmacy, medicine, microbiology, veterinary medicine, or similar field.
  • At least one year of experience within Quality Assurance or other relevant production-related job.
  • Knowledge of Good Manufacturing Practice (GMP) and associated regulations.
  • Strong communication skills with stakeholders, maintaining a respectful tone.
  • Proficiency in Danish and English, along with good IT skills.


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