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;

Management of - Complaints (SISTEMA TRACKWISE);- Supplier Qualification ( ISO 9001:2015);- SOP system- Batch Release (SAP);- Change of control;- Risk analysis (FMEA method);- Internal and External Audit

Management of:- narcotics;- deviation/CAPA; - retain sample; - Batch record review and approval- Lab event approver: OOS/OOT;- QA ON THE SHOP FLOOR;