GVP Auditor 13

Profile: A unique expert with well involvement in Pharma industry with real long experience of GCP/GLPLGVP Reviews (Clinical Trials, CRO, PV) joined with strong GMP, Product Transfer, Technical Support, Validation, Risk Management, supply chain quality and Project Management skills etc. (GXPs… GMP/GCP/GVP, GLP), RcA Root Cause Analysis, Failure Investigation, Operational Excellence OE, Quality by Design QbD and overall process improvement. HSAS / ISO; 17025, 14001, 18000 especially 9001, 13485, MDD, US Federal Standards 209 E and DIN Standards of Germany. Specialties: Clinical, Technology & Product Development and Transfer, Project Management, Validation, Qualification, IQ/OQ/PQ, Auditing, Supply Chain Management, Compliance, CAPA and Remediation, Manufacturing, QA, QC, R&D, Risk Assessment, and Training. Skills include Computer: Win, MS Office, MS Project, PRISMA, PlanIsWare, ORACLE, BPCS, BIMS, StepQ, Lotus, Darius, SOLIDS, IsoTrain. Analytical software: NWA QUALITY ANALYST, STATISTICA, Stat-Graphics, Minitab .Ok for auditing services in Middle East, Turkey, Africa, India, Pakistan & CIS countries. Languages Known: English (Proficient),French (Beginner),Arabic (Fluent). Based in Dubai, United Arab Emirates.