Stability Specialist for Global Quality Team

1 month ago


Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full time
About the Role

This is an exciting opportunity to join the Global Quality team at Fujifilm Diosynth Biotechnologies as a Stability Specialist. In this role, you will be responsible for managing stability studies and supporting procedures and projects.

Key Responsibilities:

  • Author and maintain stability protocols and specifications
  • Create Change Controls within the stability area
  • Build and maintain stability studies in LIMS
  • Create final stability data reports to customers
  • Be responsible for stability chambers
  • Create and maintain contracts covering stability and additional QC services
  • Support QC Sample Handling and Shipping documentation
  • Drive projects within the team
  • Participate as a Subject Matter Expert in customer and regulatory audits
  • Participate/facilitate meetings globally and with customers
About You

To be successful in this role, you will have a degree in Natural Science or a similar field, with a minimum of 5 years of relevant experience from the pharmaceutical industry. You should have knowledge of stability requirements and GMP Quality Systems, as well as excellent verbal and writing communication skills in English.

What We Offer

  • A competitive salary range: $80,000 - $120,000 per annum
  • A dynamic and supportive work environment


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