Research and Development Quality Assurance Specialist

7 days ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Position

As a key member of the QC Stability Team, you will be responsible for handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. You will work closely with stakeholders such as customers, project managers, management, your own department, and QA to identify and manage analytical stability packages needed for projects.

Your primary responsibilities include:

  • Writing and reviewing CAPA documents, deviations, and change controls
  • Developing and reviewing customer-specific stability protocols and reports
  • Collaborating with customers on stability-related topics
  • Overseeing testing at external laboratories
  • Evaluating compliance with relevant cGMP guidelines (EU, FDA)

About the Department

You will join the QC Support team in the QC laboratory, where you will collaborate with highly dedicated scientists and technicians. The QC Support department consists of three teams: QC Raw materials, QC Samples & Service, and QC Stability.

About the Ideal Candidate

We are seeking an MSc holder in Biochemistry, Pharmaceutical Sciences, or a related field with relevant experience in quality control or quality assurance. In addition to this, we expect the ideal candidate to possess some of the following skills and qualifications:

  • Strong knowledge of DS/DP stability and cGMP principles
  • Experience in managing change controls, deviations, and CAPAs
  • Knowledge of chromatographic and bioassay methods
  • Excellent communication skills in English, both spoken and written
  • Demonstrated ability to drive continuous improvement and productivity programs
  • A team player with the ability to work independently

The ideal candidate thrives in a dynamic environment and enjoys a rapid pace of work. They bring a positive attitude and a good sense of humor.



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