Personal Information
Organization / Workplace
Basel Area, Switzerland Switzerland
Occupation
Novartis Pharmaceutical Global Program Quality Assurance Leader
Industry
Technology / Software / Internet
About
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
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