Guido Bora Email & Phone Number

Aprilia, It

Latina, Italia

I have been working as Aseptic Filling operator for four years developing high knowledge in Maintenance and Cleaning (CIP, SIP) of Equipment in compliance with current SOPs and cGMPs rules in place. Main Activities performed:•Perform daily and weekly operator checks.•Document all events, such as stops, starts, splices and troubleshooting.•Perform nominal maintenance on equipment.•Monitor and report aseptic area environmental conditions.•Troubleshoot process equipment and interacts with maintenance personnel. •Maintain aseptic gowning requirements.•Set up and adjust filling equipment settings to meet process parameters.•Clean and sanitize fill equipment and aseptic area per SOP.Main Skills Acquired:•Practices of aseptic techniques•In depth knowledge of operation of equipment of the following equipment: RRU (Bosch Washer), Depyrogenation / Sterilization Tunnel, Autoclaves, Aseptic Filling Equipment, Capping Equipment (VRK Bosch) and Automatic Visual Inspection.•In depth Clean in Place (CIP) knowledge and capability of cleaning.•Disinfectant techniques & cleaning (internal and external) and capability for requalification & validation of systems.•In depth Steam in Place (SIP) knowledge and capability of steam sterilization, capability for requalification & validation of systems.•In depth knowledge and capability of Control of Raw Materials and Dispensing•In depth knowledge and capability of Batch Manufacture and systems

Latina, Italia

Main Activities Performed:•Packaging operations according to Batch Production Record specifications.• Completed all required documentation and calculations related to batch documentation.•In-process quality checks of finished product and documents in-process checks in the batch records.Main Skills Acquired:•Good knowledge on how to Assemble, disassemble and clean equipment and process rooms according to SOP’s.•Good knowledge to accomplish basic operation of computer controlled equipment.

High School Diploma, Perito In Elettronica E Telecomunicazioni, 80/100

English