I have achieved deep knowledge of pharmaceutical manufacturing processes, digital delivery, and IT & GMP Compliance. Thanks to the work experiences in the validation of computerized systems for Pharma Industry, I gained relevant skills on: validation strategy, risk-based approach and testing of GxP systems, GAMP5, 21 CFR Part 11, Annex 11 and Data Integrity guidelines.In the last years I enforced my expertise in the Project Management and Consulting Services in the GxP areas by leading several digitalizing projects and consulting studies for Italian and International Life Sciences Companies with specific focus in Serialization, Manufacturing, Quality & Data Integrity, IT Compliance and Laboratory.In LifeBee I have been Business Unit Manager since January 2022 achieving a consolidated experiences and skills in Team Management, Project Management, Business’s Finance management, Planning and Leadership.Key Responsibilities• Process Analysis, Feasibilities studies and Solution Design in GxP Fields• User & Functional Requirements Analysis and Definition• Project Management (planning, reporting, risk analysis, escalation)• Team Management (staffing, allocation, performance monitoring)• Business's Financial Management (budget, cost control, sales activities)• Consulting Services (lead consulting activities and cross-functional Teams)Key Topics: GxP Digital Solutions, Operational Excellence, Serialization & Traceability, Data Integrity, Contamination Control Strategy, GxP Digital Transformation Roadmap, IDMP, Plant Intelligence and Plan Data Collection, CPP/CQA Parameters Analysis, Laboratory Lean Conceptual Layout, Green Lab, IT Compliance, Validation, Process& GxP Compliance Risk Analysis,

Leading digitalizing projects with specific focus in Serialization, Production, Quality & Data Integrity and Laboratory.• Process Analysis, Feasibilities studies and Solution Design• User & Functional Requirements Analysis and Definition• Project Management (planning, reporting, risk analysis, escalation)• Team Management (staffing, allocation, performance monitoring)• Project Financial Management (budget and cost control)• Validation Strategy definition and Validation management

Responsible of Software Validation Lifecycle (Computerized System Validation) and support the Software Team in development and release process.Coordinate Validation Engineers team; support equipment qualification and validation process, review and approve validation protocols for computerized systems (risk analysis, impact assessment, design specifications, IQ/OQ test scripts) and for Serialization project as well.Responsible of Quality Department defining the Standard Operating Procedure, monitoring the Change Management and CAPA process.Coordinate internal audit and audit from Pharmaceutical companies.Has High level knowledge of validation process for Computerized System according to GAMP5 Risk-Based approach Has knowledge of FDA regulation 21 CFR Part 11, 210 and 211, Data Integrity and compliance with cGMP, European Eudralex EU Volume 4, Annex 11 and 15.Has experience in serialization and aggregation process and knowledge of traceability regulations, GS1 standard and EPCIS.Has knowledge of pharmaceutical packaging process and printing technologies; OCV/OCR applications and characters recognition algorithms; linear code and 2D code applications, code quality verification (Standard ISO 15416 and 15415).Has good experience in the Quality System management and improvement process, Change Management and CAPA process; knowledge of ISO Standards 9000 and ISO 9001.

Coordinate Software Development Team and R&D activities, creating a new approach of Software Lifecycle and validation process.Software Developer for vision inspection systems.Service Engineer at customers’ sites across Italy and Europe; support commissioning and qualification of equipment in the pharmaceutical packaging lines