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Head of QA

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Sophie Steels
Recruiter



Sophie Steels
Recruiter


Job description

  • Quality Management System
  • Compliance
  • Audit Program
  • Training
  • Monitoring and control of the manufacturing environment;
  • Process validation;
  •  Authorization of written procedures and other documents, including amendments;
  • Production site hygiene;
  • Approval and monitoring of suppliers of materials;
  • Approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
  • Designation and monitoring of storage conditions for materials and products;
  • Communicate with the regulatory authorities;
  • Application and maintenance of GMP license for EV drug manufacturing;
  • Tech Transfer Communication to CDMO’s.

Profile

  • Education: Bachelors is preferred or any other certifications related to the Quality systems
  • Minimum 10 years relevant experience
  • Experienced in Advanced Therapy Medicinal product (ATMP) is required
  • Language requirements: Dutch and English

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