Quality System & Compliance Manager

• Mar 2022 - Present

- Ensure compliance with all applicable regulations and standards within the scope of the site's Quality Management System, governing the manufacturing and release of the Medical Device, ThermaCare - Develop, implement, and monitor Quality and Regulations Compliance strategies - Always maintain a state of readiness for inspections - Supplier Qualification and Monitoring - Documentation Control and Training Management - Ensure compliance with all applicable regulations and standards within the scope of the site's Quality Management System, governing the manufacturing and release of the Medical Device, ThermaCare - Develop, implement, and monitor Quality and Regulations Compliance strategies - Always maintain a state of readiness for inspections - Supplier Qualification and Monitoring - Documentation Control and Training Management

Global Quality Audit & Supplier Quality Assurance

• Sep 2021 - May 2023

Industrial Quality Audit

• Jan 2019 - Sep 2021

- Perform internal quality audits to Angelini subsidiaries, HQ functions and Angelini manufacturing/distribution sites.- Perform supplier/contractor quality audits on international basis for production/distribution of APIs, excipients, pharmaceutical, non-pharmaceutical products (cosmetics, food supplements, MDs, biocides, detergents).- Collaborate in the preparation and management of external inspections carried out by Health Authorities, Notified Bodies, customers at all relevant company sites and CMOs. Show less

Suppliers Quality

• Aug 2016 - Dec 2018

- Qualification, approval, maintenance and monitoring of suppliers of pharmaceutical and non-pharmaceutical products (MDs, biocides, detergents).- Quality Agreement negotiation.- Handling of deviations and complaints from the market.- Change control management.- Execution of suppliers audits.

Company Manufacturing Compliance

• Jan 2015 - Aug 2016

- Management of module 3 e-CTD variations through Documentum and Extedo softwares.- Management of Product Information Files for cosmetics through Eucostar software.- “Idee vincenti” award for a teamwork realised through the OOBEYA methodology in the launch of a commercial promotion, 2016.