Description
Job description:
- Start: ASAP
- Duration: 6 months
- Location: Basel
Requirements:
- 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:
- 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
- BSc in a relevant scientific discipline
- Strong PC skills including MS Office