Roberto Bertini

Partner & Technical Operations Vice President @PQE Group

Rome, IT

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Apr 2021 — Present

Partner & Technical Operations Vice President @PQE Group

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Rome, IT

EDUCATION

N/A

Sapienza Università di Roma

Bachelor's degree

SKILLS

GmpQuality SystemV&VU.s. Food and Drug Administration (Fda)Regulatory AffairsRegulatory RequirementsComputer System ValidationU.s. Title 21 Cfr Part 11 RegulationPharmaceutical IndustrySopFdaProcess EngineeringSix SigmaGxpQuality AuditingChange ControlIso 13485CapaGampValidation21 Cfr Part 11Corrective and Preventive Action (Capa)Quality AssuranceTechnology Transfer

ABOUT ROBERTO BERTINI

25 years’ experience long career in Computerised Systems Validation and Data Integrity assurance. After graduating in Physics at the University of “La Sapienza” in Rome, I joined PQE Group in Partner and currently Global Operations Director leading the CSV and DI service deliveryI personally managed the validation process of most common Computerised Systems used in the Life Science environment (e.g. ERP, MES, LIMS, WMS, Lab Systems, PCS, Serialization domain) and supported the implementation of Quality Management Systems for the IT governance. I am now supporting a number of pharmaceutical companies in the implementation of Data Integrity Governance and in the related Data Integrity Programs including QMS foundation, assessment and remediations.

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