* Serve as the primary quality contact for all communications related to drug substance and drug product PPQ
* Review and approve PPQ documentation including protocols, reports and discrepancies
* Review executed PPQ batch records and ensure accurate transcription into reports
* Ensure discrepancies during execution are fully investigated and assessed for PPQ impact
* Participate in FMEA and other risk-based activities to evaluate process performance
* Provide regular updates on PPQ progress and escalate delays, failures or issues in a timely way
* Act as the main quality representative in project teams, escalating when needed and ensuring cross-functional alignment
* Occasional travel may be required
Competences
* Minimum 5 years of experience in Quality or Process Validation
* Strong GMP knowledge, especially for small molecule drug substance and drug product operations
* Skilled in managing multiple priorities in a fast-paced environment
* Experience collaborating with CMC, regulatory, MSAT and other quality functions across countries and time zones
* Strong ability to evaluate quality risks and propose mitigation strategies
Maybe not for you, but for someone else?
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