QA GMP Compliance support Consultant

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, including associated CAPAs
• Provide daily status and progress reporting to management

To find out more about Real please visit www.realstaffing.com