Related skills
sap gmp capa trackwise gdp📋 Description
- QA release oversight for GMP and GDP compliance
- Act as QP delegate for certification and release of IMPs
- Coordinate with CSQ and global QA teams for timely releases
- Review batch documentation and analytical results
- Lead QA process improvements and drive compliant practices
- Coach teams in quality practices and audit readiness
🎯 Requirements
- Certified Industrial Pharmacist with 5+ years pharma exp
- Deep knowledge of GMP, GDP, CT Regulations
- Fluent in English and Dutch (spoken and written)
- Experience with SAP, RIMS/TruVAULT, Summit, Trackwise, COMET, eLIMS, MS Office
- Strong analytical thinking, decision making and leadership
- Excellent communication with internal/external customers
🎁 Benefits
- Equal opportunity employer
- Global CRO with 28+ years in clinical development
- Collaborative, multinational teams and ongoing training
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