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.
August 2012 --- January 2014
I worked for an international pharmaceutical company (Novartis Vaccines & Diagnostics, Siena/Rosia sites) in Qualification Department. My main responsabilities and activities were: Developed and executed Design, Installation and Operational Qualification Protocols, wrote and attained approval of corresponding Qualification Reports for Lab Systems in compliance to 21 CFR Part 11 guidelines and EU GMP Annex 11. Developed Design, Installation and Operational Qualification Protocols and Traceability Matrix, wrote and attained approval of corresponding Qualification Reports for Equipment (autoclaves, freeze- dryers, freezers, centrifuges, glass- washers, isolators). Developed and reviewed Design, Installation and Operational Qualification Protocols, wrote and attained approval of corresponding Qualification Reports for Automation Systems (BAS, BMS, PAS, MFCS) in compliance to 21 CFR Part 11 guidelines and EU GMP Annex 11. Documented, reported, resolved and attained approval of Deviation Reports. Assisted the Qualification Department in ongoing annual re-qualification for Computer Systems. Performed plant shutdown operations. Supervisor and reviewer of FAT and SAT on site. Planning of review and qualification activities.
April 2012 --- August 2012
Developed and executed Installation and Operational Qualification Protocols for Lab Systems.
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) Certification