Marisa Cappelli - WIZBII Marisa Cappelli a publié son profil professionnel sur WIZBII. M C

Marisa Cappelli

38 ans • Sezze

Expériences

IT&CSV Consultant

- MaintenantFirst level support for end user of Empower 3 (Global System) and NuGenesis (local data storage system) systems as System Administrator - Data Integrity Projects - Medical Devices software Risk Assessment - Coordination between different departments (IT \ CSV, Maintenance Calibration, Qualification Commissioning, Quality Control, Quality Assurance and Production) and suppliers involved in the implementation of systems - Coordination of qualification activities for guarantee the compliance of laboratory systems in case of: implementation of new systems, upgrade for introduction of technology improvement (operating systems, application systems) - Validation of computerized systems according to main applicable regulations: EudraLex, FDA 21 CFR parts 210 & 211, Part 820, Part 11 - Issue and execution of compliance documentation: Project Plan, Compliance Plan, Compliance Analysis, User Requirements Specifications, Criticality Analysis for Electronic Record / Electronic Signature, Risk Analysis, Functional Specifications, Design Specifications, Hardware & Software Specifications, Traceability Matrix, Data Migration Plan and Report, System Test Protocols - Computer System Validation - Technical support and change control on computerized systems - Business Management of IT Changes - IT Logical Security - Testing of GMP Software Applications - IT Systems Monitoring Activities

Formations

Université La Sapienza (Italie)

2012 - 2018 Rome, Metropolitan City of Rome, Italy, RomeConception / Génie civil / Génie industriel
Faire de chaque avenir une réussite.
  • Annuaire emplois
  • Annuaire entreprises
  • Événements
    •