Michele Volpe Email
Validation and Sterility QA Manager @ Altergon Italia
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Michele Volpe Location
- Naples, IT
Michele Volpe Work
- Validation and Sterility QA Manager @ (October 2025 - Present)
- QA Operations, Validation and Sterility Assurance Manager @ (January 2018 - May 2026)
- QA Operations Manager @ (October 2012 - December 2018)
- Validation Manager @ (December 2003 - September 2012)
- Calibration and Validation Coordinator @ (January 2003 - December 2003)
- Calibration and Validation Technician @ (December 1999 - December 2002)
Michele Volpe Education
- Università degli Studi eCampus
ENGINEERING
2018-2021 - Istituto Tecnico Industriale
Diplomato (Elettronica)
1987-1992
Michele Volpe Skills
- 21 CFR Part 11
- Aseptic Processing
- Audit IT
- Audit esterni
- Audit interni
- Auditing
- Azioni correttive e preventive
- Batch Release
- Biofarmaceutica
- Biotecnologia
- Buone pratiche (GxP)
- CAPA
- Calibration
- Change control
- Cleaning Validation
- Cleanroom Compliance (ISO 14644 / GMP classified areas)
- Commissioning
- Commissioning & Qualification
- Compliance
- Computer System Validation
- Computer System Validation (CSV)
- Contamination Control
- Continuous improvement
- Controllo qualità
- Convalida
- Convalida dei metodi di pulizia
- Deviation Managment
- Deviazioni
- Documentazione tecnica
- EU GMP Annex 1
- Environmental Monitoring (EM)
- Equipment Qualification (DQ/IQ/OQ/PQ)
- FDA
- Farmaceutica
- GAMP
- GMP
- Gestione dei cambiamenti
- Gestione dei dati
- Gestione dei reclami
- Gestione qualità
- Good Automated Manufacturing Practice (GAMP)
- GxP
- Health Authority Inspections
- Industria farmaceutica
- Ispezione
- Key Performance Indicator
- Leadership
- Manifattura
- Manutenzione preventiva programmata
- Norme di buona fabbricazione
- Notified Body Audits (EU MDR)
- Pharmaceutical Industry
- Problem solving
- Process Failure Mode and Effects Analysis (PFMEA)
- Process Validation
- Project Management
- Quality Assurance
- Quality Control
- Quality System
- Quality Systems
- Qualità del prodotto
- Regulatory Affairs
- Regulatory Inspection Management
- Risk Analysis
- SOP
- Sistema di qualità
- Sterility Assurance
- Sterility Assurance
- Strumenti medicali
- Sviluppo del personale
- Sviluppo delle persone
- Team building
- Team leadership
- Trasferimento tecnologico
- Trattamento asettico
- Validation
- Validazione dei sistemi informatici
- Verifica e validazione
- Buone Pratiche Gxp
- Good Automated Manufacturing Practice Gamp
- Buone Pratiche
- Good Automated Manufacturing Practice
Michele Volpe Summary
- Michele Volpe, based in Naples, IT, is currently a Validation and Sterility QA Manager at Altergon Italia. Michele Volpe brings experience from previous roles at Kedrion Biopharma. Michele Volpe holds a 2018 - 2021 ENGINEERING @ Università degli Studi eCampus. With a robust skill set that includes 21 CFR Part 11, Aseptic Processing, Audit IT, Audit esterni, Audit interni and more. Michele Volpe has 2 emails on RocketReach.
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