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Stefano Gentili

Stefano Gentili

Commissioning and Validation

Talento
Rome, Roma Capitale, RomaMembro dal 4 ottobre 2024
Commissioning and ValidationProduction management (over 40 workers)Production scheduleFDA and GMP knowledge and applicationLEAN knowledge and applicationAseptic ProductionEquipment sterilizationEngineering and industrializations of new production systemsProduction systems management (new machines and systems, maintenances and validaCommissioningConsumable production materials suppliesAudit customers and inspectorsCost accountingBudgetingEquipment qualificationSystems validationComplianceRaw materials warehouse managmentAseptic Production: Compounding and FillingProject and design of safety and control devices for industrial systemsPipe design for water, steam, gas and HVACP&ID drawingApplications of Safety&healt Italian lawManagement of periodical inspection on pressure device and steam generator (ARPADocumental Analysis on machines and residual risk analysis
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Commissioning and ValidationProduction management (over 40 workers)Production scheduleFDA and GMP knowledge and applicationLEAN knowledge and application

Info

I'm a Engineer with several years of experiences in Production area.

From 2013 to 2023 I was a production departments responsible, eight years in aseptic filling (liquids and ointments), packaging operations, consumable materials warehouse management, two years in compounding (aseptic) of eye drops, ointements and lyophilized products, raw materials dispensing and wharehouse management, equipment washing and sterilization.

During my production experiences I’ve managed several workers, about 40 in the same time, divided in many departements. During this time I have always been at the forefront with customers and inspectors. I’m always involved in many projects such as implementation of new products, implementation of new equipment and systems, facility modifying, FDA / AIFA authorization, continuous improvement (LEAN and Operational Excellence).

During my first years of work (2012), employed in the Engineering team, I worked on maintenance, safety devices design, Pipes design, P&ID drawings, Risk Analysis.

Today, I am committed to the quality assurance validation department, a new professional challenge that provides me with great opportunities to develop and improve my professional skills.

Kind regards

Stefano Gentili

Esperienza

I'm a Engineer, actually engaged in Quality Assurance Department, with several years of experiences in Production area.

From 2013 to 2023 I was a production departments responsible, eight years in aseptic filling (liquids and ointments), packaging operations, consumable materials warehouse management, two years in compounding (aseptic) of eye drops, ointements and lyophilized products, raw materials dispensing and wharehouse management, equipment washing and sterilization.

During my production experiences I’ve managed several workers, about 40 in the same time, divided in many departements. During this time I have always been at the forefront with customers and inspectors. I’m always involved in many projects such as implementation of new products, implementation of new equipment and systems, facility modifying, FDA / AIFA authorization, continuous improvement (LEAN and Operational Excellence).

During my first years of work (2012), employed in the Engineering team, I worked on maintenance, safety devices design, Pipes design, P&ID drawings, Risk Analysis.

Today, I am committed to the quality assurance validation department, focused on qualification and validation activities, project management and commissioning

Formazione

Operation management

Competenze

Commissioning and Validation

Recensioni