Quality Assurance Specialist for Pharmaceutical Manufacturing

6 days ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time
Job Overview

We are seeking a highly skilled Quality Assurance Specialist to join our Aseptic Manufacturing team in Kalundborg. As a key member of our Environmental Monitoring Team, you will play a crucial role in ensuring the quality and compliance of our products.

About the Role

In close collaboration with colleagues, you will be responsible for reviewing and approving batch documentation, trend reports, Standard Operating Procedures (SOPs), and deviations related to Environmental Monitoring. Your expertise will help us maintain the highest standards of quality and compliance in our production processes.

Main Responsibilities
  • Review and approval of batch documentation and supporting processes.
  • Perform QA oversight and observe performance of processes to identify areas for improvement.
  • Advise stakeholders on quality matters to ensure the right level of quality in production processes.
  • Participate in inspections by authorities and present cases as required.
  • Contribute to process improvements in your working area.
Requirements
  • Bachelor's degree in pharmacy, medicine, microbiology, veterinary medicine, or similar field.
  • 1 year of experience in QA or relevant production-related job is advantageous.
  • Knowledge of Good Manufacturing Practice (GMP) and regulations.
  • Strong communication skills with stakeholders, maintaining a respectful tone.
  • Proficiency in Danish and English (both oral and written), along with good IT skills.
About Us

Aseptic Manufacturing QA in Kalundborg is a well-functioning department with many interfaces within the organization. We are a team of 60 engaged employees with a great team spirit, and we overcome obstacles with open and honest communication. Our main task is to help set and ensure the quality direction of our production area, thereby having direct impact on products delivered to patients all over the world.

Working at Novo Nordisk

At Novo Nordisk, we use our competencies, dedication, and ambitions to help many people improve their lives. At the same time, we offer the opportunity to become part of a global workplace where you work with talented colleagues and where your passion and commitment are met with opportunities for personal and professional development.



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