Simone D'Agostino

Experienced in ensuring high-quality standards for IT systems, focusing on regulatory compliance (CFR21 Part 11, GAMP5) and Computerized System Validation (CSV). Skilled in performing IQ/OQ/PQ testing, risk assessments, data integrity compliance (ALCOA+), and ERES requirements.

Proficient in validating critical IT processes, including MES and SCADA systems. Adept at collaborating with cross-functional teams to ensure GxP compliance and maintain quality across IT operations.

• Enhanced data integrity and system reliability by implementing robust and efficient validation processes for CSV projects, ensuring seamless alignment with regulatory requirements.
• Developed and standardized change control protocols, enabling precise tracking, documentation, and approval of system modifications to maintain audit readiness.
• Optimized regulatory compliance by rigorously applying CSV guidelines and industry best practices, driving consistent adherence to quality standards.

10/2015 – 2016 | IT Application and QC Lab Systems Specialist
As an IT Application Specialist for TRD and QC departments, I ensure business system availability and reliability. Key responsibilities include incident management, troubleshooting, vendor coordination, data archiving, retention management, and IT quality project oversight.

08/2016 – 2017 | Novartis Business Services, Siena
Quality Systems - Validation Team Lead
Led the validation team during the NVS-GSK.CSL acquisition transition. Developed documentation detailing system and data transfer processes, aligning with Novartis Information Governance Management Procedures (IGMP) and ensuring compliance with Data Integrity and CGMP guidelines.

07/2017 – 2018 | AbbVie SrL
Validation Engineer – Manufacturing Department
Responsible for the installation and validation of a new packaging line, SCADA systems validation, and validation of production equipment, including HVAC, V-Blender, and Reactors.