Simone Esposito Email & Phone Number

Aprilia, IT

Aprilia, Lazio, Italy

• Management of Lab QC and Manufacturing computer systems respecting Data Integrity in according to CFR 21 Part 11.
• Performing Periodic Review of Lab QC and Manufacturing equipment, consulting Change Control and CAPA management in case of quality impact on the equipment mentioned above.
• Monitoring of project state and the relative planned activities through weekly meetings with stakeholders.

Latina, Lazio, Italia

• Stakeholder coordination, monitoring the relative activities through GANTT planning and weekly meetings.
• Main contact for clients to gather their requests and discuss topics, such as materials incoming, non-conformities, Change Control, new proposals, manufacturing planning changes and any.
• Owner for the projects time/cost management.

• Main Customers: Pfizer, Menarini
• Qualification by "verification" method;
• Cleaning Validations of Blistering and Compressing machines with relative risk Assessment by FMEA approach;
• GAP analyses between Pharmacopoeiae and international refernece standards.

• Main Customers: Dompé, PharOS Ltd (Malta).
• Qualification Verification of NGF Secondary Packaging Line and utility HVAC;
• Qualification of QC Lab. and Manufacturing equipment.;
• Drafting and reviewing of qualification documentation (URS, GxP registration, protocols, reports, release forms).

Pomezia, Lazio, Italia

• Scaling up of products under development and management of regulatory and QA aspects for process transfer activities.
• Supervision of validation processes in production department, with particular attention to any critical issues found in the R&D area and related corrective strategies.
• Management of QA aspects (CAPA and non-compliance).
• Computer System Validation (CSV) in compliance with Data Integrity.

Pomezia, Lazio, Italia

• Curricular internship for the experimental thesis linked to the Master’s in CTF.
• Support in the management of regulatory and QA aspects for process transfer and qualification activities.
• Execution of tests concerning the verifications programmed by QA (tests on thermo-hygrometric probes, UV lamps, tachometers, particle counts, pressure switches, pressure gauges, etc...).
• Production of process validation reports and holding time studies.

Eqf: Level N° 7, Degree In Pharmaceutical Chemistry And Technology, 110/110 Cum Laude

Activities and Societies: Thesis title: "Technological transfer in a new fluid bed granulation plant and distribution of micro-tablets.

Master Executive In Project Management, Project Management

Predictive Project Management Agile Project Management Rick Management in projects IT support instruments for Project Management