Plant management - Process Improvement - New Projets ( Feseability - Basic Design) - Validation Managment - Budget Definition - HSE Managment - QA Managment - Risk Assesment - Projet Managment - People Coaching – External Supplier Management – Temas Management

I lead the Process Changes and the Validation effort in Pharmaceutical Science Dpt. I support the technical continuous improvement and the manufacturing process refurbishment. We have several streams, oral solid, inhalation, clean liquid, lyo production, API Plant Production, API development. AIFA and FDA have granted their approval to the facility. I ensure timely execution of projects identifying potential bottlenecks. I usually have technical interactions with internal and external process scientists. I coordinate the resources dedicated to the projects.

I was responsible of Process Technology Unit composed of 5 people. Aim was to implement Process Technology in production lines. The Unit worked for GSK Verona and Parma sites, focusing on optimization of secondary production processes and packaging. My team was covering projects from the approval of User Requirements Specification (URS) up to Performance Qualification (PQ) and first production trials. All devices and process were successfully approved by Regulatory Authorities (FDA and AIFA). I was directly responsible of Validation Activities. Below are listed some projects: - New presentation (MonoVial for the European Market) - Vial Bio & ampoules inspection process. - New presentation (ADD-VANTAGE for the USA Market) - Refurbishment of Bio vial filling line 1 - Packaging Line for Japanese market - Freeze Drying Bio dept.