BrightOwl Loader Loading

Experiences

Current Experience

  • Project Quality Engineer


    Since January 2014
    i am an external Consultant and i am working for an international Pharmaceutical company (novartis Vaccines, rosia/siena sites) in ecompliance department, as project quality Engineer. my main responsabilities and activities are listed below: assessed eres Compliance and provided reports with remediation recommendations for GXP computerized systems. presented eres gap assessment results. maintained an inventory of over 1000 Manufacturing GXP systems, including Validation Compliance and eres Compliance. identified issues and resolved at root cause by capas with respect to criticality, risk/severity and regulatory/business requirements for computerized systems. provided qa Technical Support for computerized systems. quality review of Excel spreadsheets used for GMP purpose. quality review of standard operating procedures, Qualification protocols, technical and systems development lifecycle Documentation (user requirements specifications, functional Risk Assessment), traceability matrix, Validation plan and Validation summary reports. quality review of computerized systems re-evaluations in order to verify that the computerized systems remain compliant with regulatory requirements, fit for intended use, and satisfy corporate policies and procedures. interfaces with customers and suppliers on quality related issues. as a representative of qa, acquired and maintained rapport with management and executives across qc/t&d laboratories, it, Engineering, Operations (local sites). extensive knowledge of current FDA regulations for electronic records, 21 CFR Part 11, systems development lifecycle and cGMP regulations and cGMP Compliance. I am an external consultant and I am working for an international pharmaceutical company (Novartis Vaccines, Rosia/Siena sites) in eCompliance Department, as Project Quality Engineer. My main responsabilities and activities are listed below: Assessed ERES compliance and provided reports with remediation recommendations for GxP computerized systems. Presented ERES gap assessment results. Maintained an inventory of over 1000 manufacturing GxP systems, including validation compliance and ERES compliance. Identified issues and resolved at root cause by CAPAs with respect to criticality, risk/severity and regulatory/business requirements for computerized systems. Provided QA technical support for computerized systems. Quality review of Excel spreadsheets used for GMP purpose. Quality review of Standard Operating Procedures, Qualification Protocols, Technical and Systems Development Lifecycle Documentation (User Requirements Specifications, Functional Risk Assessment), Traceability Matrix, Validation Plan and Validation Summary reports. Quality review of computerized systems re-evaluations in order to verify that the computerized systems remain compliant with regulatory requirements, fit for intended use, and satisfy corporate policies and procedures. Interfaces with customers and suppliers on quality related issues. As a representative of QA, acquired and maintained rapport with management and executives across QC/T&D Laboratories, IT, Engineering, Operations (local sites). Extensive knowledge of current FDA regulations for electronic records, 21 CFR Part 11, Systems Development Lifecycle and cGMP regulations and cGMP compliance.

Past Experience

Knowledge

LinkedIn Assessment :
Quality SystemQuality AssuranceConvalidaSOPChange ControlValidazione dei sistemi informaticiSistema di qualitFDA21 CFR Part 11ValidationCAPAComputer System ValidationGAMPBuone pratiche (GxP)Azioni correttive e preventiveProject ManagementGMPCommissioningPharmaceuticsEngineeringIndustria FarmacVerifica e validazioneGood Automated Manufacturing Practice (GAMP)Controllo qualitIngegneriaDocumentazioneGestione qualitFarmaceuticaProject Management

Education

  • Master Aziendale in Qualità e certificazione di prodotto nelle aziende agroalimentari from CTQ in 2012
  • Ingegneria Chimica in Agroalimentare e Biotecnologico from Università della Calabria in 2010

Training and Certification

  • Livello di conoscenza dell'inglese Duolingo: Avanzato (stimato) in 0000 Certification

Area / Region

Siena, Province of Siena, Italy

Others

Driving License
  • No

Similar Candidates

Other Candidates in Italy

Other Candidates in Siena

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like