Tasks

  • Serve as the primary quality point of contact for Drug Substance & Drug Product PPQ activities
  • Review and approve all PPQ-related documentation (protocols, reports, discrepancies, etc.)
  • Review executed PPQ batch records and ensure accurate transcription into reports
  • Ensure all execution discrepancies are properly investigated and PPQ impact is assessed
  • Participate in risk-based assessments (e.g., FMEA) to evaluate process performance
  • Provide regular updates on PPQ progress and escalate issues (PPQ failures, delays) in a timely manner
  • Act as the main quality representative in cross-functional project teams
  • Occasional travel as required

Qualifications

  • Minimum 5 years of experience in Quality or Process Validation
  • Strong knowledge of GMP, specifically for small molecule drug substance and drug product manufacturing
  • Ability to manage time effectively and prioritize multiple tasks in a fast-paced environment
  • Experience collaborating with CMC, Regulatory, MSAT, and other quality functions across countries and time zones
  • Strong ability to assess quality risks and propose risk mitigation strategies