Experience

Kedrion Biopharma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manufacturing Compliance Specialist (Group Quality Compliance)

  • Jan 2017 - Present

  Group policies drafting and reviewing on TrackWise system. Internal and external auditing. Quality by design, Process validation, and lifecycle approach. Technology transfer protocol review and execution, team coordination). Impact analysis of change requests and deviations, CAPAs, in the Trackwise system. Regulatory submission documents review

• Quality Assurance / Process Validation / Cleaning Validation

  • Jun 2013 - Dec 2016

  Process validation, cleaning validation, risk analysis (HACCP, FMEA, FMECA, FTA, RTA, REM), coordination of validation teams. Validation Master plan drafting. Technology transfer. Participation in inspections by external bodies (FDA, AIFA, other regulatory agencies, and clients). Use of TrackWise for Document management, change requests, deviations and CAPAs. Regulatory submission documents review.

• Quality Control

  • Jan 2009 - May 2013

  Method development and validation, routine analysis. Expert in several analytical methods, such as: spectrophotometry, AES, immunoenzymatic methods (ELISA, MEIA, ECLIA), endotoxin assay, nephelometry, Kjeldahl, potentiometric pH, electrophoresis, coagulation factors (chromogenic, and coagulation methods), cell based methods (ACA, Fc function, agglutination tests), and immunodiffusion. Instrument management (IQ, OQ, PQ and lifecycle management). Use of TrackWise for documentation management.



Università degli Studi di Perugia

• Italy
• Research
• 700 & Above Employee

• Postdoctoral Researcher

  • Apr 2003 - Dec 2008

  Project coordination. molecular biology research Project coordination. molecular biology research



University of Zurich

• Switzerland
• Higher Education
• 700 & Above Employee

• PhD student

  • Jan 1999 - Sep 2003

  Research activities in insect phisiology. Colony maintenance Research activities in insect phisiology. Colony maintenance