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Basel Area, Switzerland Switzerland

Novartis Pharmaceutical Global Program Quality Assurance Leader

Technology / Software / Internet

SPECIALIZED IN: ✔ Executive Quality Program, Risk, Service, & Project Management - Resource driven critical path focus ✔ KPI Reporting & Escalation Crisis Turnaround ✔ User Acceptance Test Management - HPQC (ALM) Manual Regression, Test Automation, Load, Stress & Performance ✔ Corrective and Preventive Management (CAPA) ✔ Experienced in the requirements of 21 CFR Parts 803, 806, 810, 811 & 820, ISO 9001, 14971 13485, CMDR and MDD regulations, QSR/820 & GAMP 5, ICH Q&A ✔ CSV, GxP, SOPs, SOX ✔ EQ, DQ, IQ, OQ, PQ’s, QP, QR, RA ✔ Data Privacy, SAN, LAN, WAN, Firewalls, Wireless, Virtualization ✔ Global Quality System Internal / External Audits ✔ Pre-Approval Inspections