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Scientist, Quality Control

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

The Position
You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material.

Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA. Along with your team members, you will work with the Stability aspects of customer projects, including to identify and manage the analytical stability packages needed for the projects.

Your responsibilities involve:

  • Writing and reviewing CR, Deviations, and CAPA documents
  • Writing and reviewing customer-specific stability protocols and reports
  • Engaging with the customers regarding stability topics
  • Overseeing testing at external laboratories
  • Ensuring cGMP compliance with relevant guidelines (EU, FDA)

The Department
You will be part of QC Support in the QC laboratory where you will join a team of highly dedicated scientists and technicians.
QC Support consists of three departments: QC Raw materials, QC Samples & Service, and QC Stability.

The Profile
The ideal candidate holds an MSc in Biochemistry, Pharmaceutical Sciences, or another relevant area and preferably with work experience within quality control or quality assurance.
In addition, we expect you to bring some of the following experience and characteristics:

  • Sound knowledge of stability of DS/DP and cGMP
  • Experience handling change controls, deviations, and CAPAs
  • Knowledgeable of chromatographic and bioassay methods
  • The ability to communicate clearly in English – both in speech and writing
  • Demonstrated experience in driving continuous improvement and/or productivity programs
  • You are a team player combined with the ability and desire to work independently

Furthermore, you thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive, can-do attitude, and a good sense of humor.

Location: Copenhagen Site

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