Quality Assurance Coordinator for Cell and Gene Therapy

5 dagen geleden


Leiden, Zuid-Holland, Nederland Galapagos Voltijd
About Galapagos

We are a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to change lives by discovering and developing life-improving medicines.

We're a team of innovators and perseverant idealists who pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators who can help us build our QA model for our expanding organization.

Job Title: Quality Assurance Coordinator for Cell and Gene Therapy

Estimated Salary: €60,000 - €80,000 per year, depending on experience

About the Role:

We are seeking a highly motivated Quality Assurance Coordinator to support our QA team in setting up, promoting and maintaining the QA model in our dynamic business environment.

As a Quality Assurance Coordinator, you will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.

Responsibilities:

  • Manage QM attributes for PoC and Central Site activities: Deviations, CAPAs, Change Controls and Complaints
  • QA batch record review
  • Support materials release and support batch release process
  • Support equipment management at our PoC locations
  • Provide QA support to the materials kitting process

Requirements:

To be successful in this role, you should have a strong background in Quality Assurance and excellent communication skills. You should also be able to work independently and as part of a team, with a high level of attention to detail and organizational skills.



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