Inspection Subject Matter Expert
Core
Technical authority for visual inspection processes (Automated and Manual) for injectable products in lyophilisation and mAbs manufacturing.
Role type
Senior IC Inspection Subject Matter Expert
Builds
Qualified and compliant visual inspection systems and processes for injectable products
Domain
Biopharmaceutical manufacturing (Lyo and mAbs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical inspection operations, lyophilisation and biologics manufacturing, defect library management, statistical analysis for baseline studies, equipment qualification lifecycle, regulatory compliance (FDA/EMA/HPRA), cross-functional collaboration
Preferred skills
Master's degree, relevant professional certifications in inspection/quality systems, Sanofi inspection procedures familiarity, project management in equipment qualification
Technologies
AVI systems, Defect Master Library (DML), FMEA documentation, statistical analysis tools
Responsibilities
Lead full qualification lifecycle of AVI systems, create and manage defect sets and the Defect Master Library, design and deliver manual inspector training programs, supervise and execute manual baseline studies, ensure regulatory compliance for 100% visual inspection, act as technical liaison across Product Supply, Manufacturing, QA, and Engineering
Seniority
Senior, hands-on IC
