Key Responsibilities

• Ensure that clinical batches are manufactured in compliance with GMP standards and Quality Agreements


• Act as a QA PIP at the CMO, providinghands‑on oversight by:
  
  
  
  • Witnessing critical sterility assurance activities (e.g. sterile setup, filling)
  
  
  • Performing GEMBA walks when required to ensure process compliance
  
  
  
  


• Escalate critical quality issues and support impact assessments in collaboration with the CMO


• Oversee Drug Product manufacturing processes, including:
  
  
  
  • Drug Substance thawing
  
  
  • Compounding
  
  
  • Filling
  
  
  • Freeze‑drying
  
  
  • Capping
  
  
  • Visual inspection
  
  
  • Storage
  
  
  
  


• Support the investigation, follow‑up, and closure of deviations, inclu...