Walter Fazzini

-Review and Approval of Protocols and Reports for Qualification and Validation
-Review and Approval of SOP, Risk Assessments, Changes, Deviations, CAPA
-Management of the Quality System
-Audit and Inspections (AGES, FDA..)
-QA Representative for Projects
-Collaboration with Engineering, Production, Regulatory

-QA Management
-Responsible for the Process Validation (oral solid and injectables)

-Participation in different technology transfer projects
-Validation Master Plan
-Risk Analysis
- Client Audit and Inspection from Authorities
-Collaboration with Production, Engineering, Regulatory
-Batch Record Review.

-Define & execute protocols through all validation phases for new and existing pharmaceutical equipments and processes: Calibration, FAT/SAT, IQ, OQ,PQ.
-Direct interface with international clients to provide technical troubleshooting and solutions to equipments and processes.