Quality Assurance
Design Quality
Quality Management System:
Document Management, SOP writing
CAPA and Change control management
Intern Audit
Risk Management
Trackwise 8 (CAPA, CCP), SAP, Minitab, Oracle Agile, Document Management
Operational Excellence - Lean and 6 sigma tools (DMAIC,VOC...)
Engineer in Biotechnology (USP, DSP, Biochemistry, Microbiology, Chemistry)
GMP,Swissmedic, FDA 21 CFR 210&211, ICH Q9 &Q10, Eudralex Vol. 4
Project Management (PMI certification)
Pre-Clinical study / R&D management
Communication skills, Proactive, good learner and listener