Roberta Chiappetta

Senior Qa Specialist @Mylan

Milano, IT

CAPA management- Develop and track CAPA process metrics to support improvement activities- Coordinate with CAPA task owners to ensure adequate documentation of the CAPA activities and actions taken in a timely manner- Maintains strong knowledge of CAPA system and procedures, drives CAPA Compliance & provides CAPA oversight;Quality Risk management (FMEA - SWOT)Internal Audit Management- Issue and review of the Internal Annual Audit Program- Perform internal Routine and Qualification Audits - Audit CAPA plan monitoringLead Auditor ISO 9001:2015 Knowledge ISO 13485 - ISO 14155 Quality Management Review (QMR)- Support the identification of Key Quality Indicators- Interprets quality performance and associated metrics and develops strategies for achieving/maintaining high levels of compliance Quality System Maintenance- SOP system- Change Control system;

Università Cattolica del Sacro Cuore

Master in Sistemi di Qualità: GxP e ISO

Università degli Studi della Calabria

Laureata