David Bini

ERP Operations Unit Manager & Senior Associate Partner @PQE Group

Florence, IT
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2022 — Present

ERP Operations Unit Manager & Senior Associate Partner @PQE Group

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Reggello, IT

EDUCATION

2004 — 2006

Università degli Studi di Firenze

PhD, Non Destructive Testing

1995 — 2003

Università degli Studi di Firenze

Bachelor of Engineering (BE), Telecommunications Engineering

SKILLS

Life Sciences21 Cfr Part 11Process EngineeringQuality AuditingData AnalysisCapaValidationGmpErpV&VLifesciencesU.s. Title 21 Cfr Part 11 RegulationC++Corrective and Preventive Action (Capa)Change ControlProject ManagementQuality AssuranceComputer System ValidationTrainingEnterprise Resource Planning (Erp)GxpTeam LeadershipQuality System

ABOUT DAVID BINI

PMP certified since 2016. Project Manager and Executive Consultant, 10+ years of experience in Project Management and Computer System Validation, IT Assessment, IT Infrastructure Qualification, Risk Analysis and Assessment to ensure the compliance with requirements and regulations given by the US FDA, EU authorities, and other International and National Standards, as well as IT, QA, Clinical rules and guidelines. Validation team coordination in terms of software system user requirements and support for implementation, release, tuning and testing of GxP critical systems for pharmaceutical and medical devices industries in Italy and Europe. IT Infrastructure team coordination for the Qualification of IT Infrastructure. Wide experience in pharmaceutical processes (analysis and mapping for production, Clinical, warehousing, QA, distribution, plant maintenance and logistics) and the associated IT solutions. Software development Skills focused in the implementation of application supporting Medical Device, Pharmaceutical and Clinical Processes. Appointed as SW Vendors / System Integrator Auditor.

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David Bini — ERP Operations Unit Manager & Senior Associate Partner at PQE Group in Florence, IT | Unifers