Melinda Di Giorgio

Quality Professional with a demonstrated history of working in the Pharmaceutical industry. Skilled in Quality Investigations, Complaints, Change Control, Deviations, CAPAs, Quality Risk Management, GxP. End-to-end Local Process Owner of Quality Systems used within Global External Manufacturing. SME in audits/ inspections and review of regulatory changes, responsible for coordination of input from key stakeholders into the impact assessment to the process.

-Participating in scheduling, planning, executing, and reporting internal audits -Developing, controlling and maintaining standard operating procedures (SOPs) and related controlled documentation -Participating in the implementation of CAPA and nonconformity programs, Deviations, Batch Recall, Change Control activities -Risk Assessment – Failure Model and Effect Analysis (FMEA) -Knowledge of: cGMP,GDP, ISO, HACCP, CFR 21- 11, ICH.

-Qualification & Calibration : creation and correction of qualification protocols IQ/OQ/PQ for pharmaceutical implants, Systems, Equipments. -Developing, controlling and maintaining SOPs and related controlled documentation. -Change Management for equipments and implants, deviations, CAPA system. -Partecipating in scheduling, planning, executing, and reporting internal audits as specified in the yearly audit schedule . -Participating in Factory/Site acceptance test (FAT/SAT).

Validation of pharmaceutical implants and equipments, Chemical Analysis of pharmaceutical products, Pharmaceutical Technology