Skills:
REGULATIONS: cGMP, GLP, FDA, QSR, ISO, CFR (21 CFR parts 210,211, 11, 820, 54, 58), EPA, GCP requirements and ICH guidelines. LABORATORY SKILLS: Evaluation of pharmaceutical products, Tablets Punching machine, Dissolution & Disintegration testing and apparatus, Thin Layer Chromatography, Gas Chromatography, Kaye Validator, Lab Notebook, Swabbing and Spiking, TOC analysis, Swab Sampling, Spiking method, Clean-In-Place, SIP. QUALITY TOOLS: Lean Manufacturing, Documentation, Process Capability, CAPA, Fish Bone Diagram, Audit, FMEA, Root Cause Analysis, Pareto Charts, Histogram, Cause and Effect analysis, Process Mapping, Poke Yoke, Kaizen. SOFTWARE: Minitab 17 (Statistical Process Control), M-Files (Electronic Document Management System), MS Project, MS Excel, MS Word, MS Power Point.