Experience

Kedrion Biopharma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Operations Supervisor

  • Dec 2022 - Present

  Biological Production QA Operations Supervisor.

• Sr. QA Operations Associate

  • Nov 2014 - Dec 2022

  - Manage deviations and the process investigations;- Plan the corrective and preventive actions;- Manage the equipment and process change requests;- Cross-functional meetings coordination.

• Quality Operations (Melville, NY)

  • Jun 2016 - Aug 2016

  During the production site shut down, I took part to a multidisciplinary team aimed to provide support in: documentation revision/preparation, instruments validation, deviation management and process investigations.



MENARINI Group

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Compliance Officer

  • Apr 2014 - Nov 2014

  - Management of 3 and 2.3 modules for new registrations or to keep the existing ones - In cooperation with Quality Assurance dep., regulatory teams or external partners, preparing the technical documentation and the answers to the regulatory authorities questions. - Management of 3 and 2.3 modules for new registrations or to keep the existing ones - In cooperation with Quality Assurance dep., regulatory teams or external partners, preparing the technical documentation and the answers to the regulatory authorities questions.



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Operations Coordinator

  • Jun 2013 - Apr 2014

  - Production documentation revision (batch record and annexes); - Provide support during the investigation activities carried out due to process deviations occurrence.

• Internship (Production Support department)

  • Mar 2013 - Jun 2013

  Process investigations management.



Università di Pisa

• Higher Education
• 700 & Above Employee

• Master Thesis

  • Feb 2012 - Nov 2012

  Computational studies to develop new inhibitors for the kinase BTK”: the purpose of our work was to find new leads able to inhibit the BTK, a kinase belonging to TEC family, which represents an interesting target for the treatment of diseases such as the chronic lymphocytic leukemia and rheumatoid arthritis. We developed a highly selective computational protocol for virtual screening, using different approaches such as pharmacophoric, docking and molecular dynamic simulation studies. The theoretical results were also confirmed by experimental studies that led to discover new BTK inhibitors. Show less