Experience

STERIS Isomedix Services (Now STERIS AST)

• United States
• Medical Equipment Manufacturing
• 300 - 400 Employee

• Site QA Manager

  • Oct 2022 - Present

  Site QA Manager Biassono and Poggio Rusco Site QA Manager Biassono and Poggio Rusco



Sirton Pharmaceuticals S.p.A.

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Officer

  • Dec 2021 - Oct 2022



Olon

• Italy
• Chemical Manufacturing
• 700 & Above Employee

• QA Specialist

  • Feb 2020 - Dec 2021

  Management and review of the quality documentation (CAPA, deviations, change control, batch records, complaints, SOP, training, Quality Agreement, etc). ▪ Procedures drawing up and implementation of modules. ▪ PQR (Product Quality Review) and Process validation drawing up and implementation (Generic API and CDMO). ▪ Management of audits (lead auditor to supplier and from customers) and self inspections ▪ Management of qualification activities (IQ, OQ ,PQ). ▪ Management of personnel training ▪Validation Master Plan update ▪Master batch records drawing up ▪ KPI management ▪ Use of SAP system Show less



Icrom Srl

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Specialist

  • Sep 2017 - Oct 2019

  ▪ Management and review of the quality documentation (CAPA, deviations, change control, batch records, complaints, SOP, training, Quality Agreement, etc). ▪ Procedures drawing up and implementation of modules. ▪ PQR (Product Quality Review) and Process validation drawing up and implementation. ▪ Assisting the QP in her activities, including authorities (FDA and AIFA) and customers audits. ▪ Managment of the qualification activities (IQ, OQ ,PQ). ▪ Management of operational personnel training ▪ Participation in the response activities for AIFA and FDA (follow-up documentation). Show less



FRANCIA FARMACEUTICI - s.r.l.

• Milano, Italia

• QA Specialist

  • Jun 2017 - Sep 2017

  • Management and revision of BR (approving, reviewing and emission of GMP certificate of release according to Annex 16). • Collaboration with the QAM for IQ, OQ, cleaning validation activities. ▪ Management and review of the quality documentation (batch records, SOPs, training, etc). ▪ SOP, Master Batch Record and module implementation. ▪ Knowledge of GMP, ISO 13485 • Management and revision of BR (approving, reviewing and emission of GMP certificate of release according to Annex 16). • Collaboration with the QAM for IQ, OQ, cleaning validation activities. ▪ Management and review of the quality documentation (batch records, SOPs, training, etc). ▪ SOP, Master Batch Record and module implementation. ▪ Knowledge of GMP, ISO 13485



Depo Pack snc

• Saronno

• QA assistant /QC Manager

  • Jan 2016 - Jun 2017

  March 2017 –June 2017: QA Assistant /QC Manager March 2016 – March 2017: QA/QC specialist (QA Manager ad interim for 8 month) Company operating as a third parties secondary packaging for medicinal products and preparation of clinical trials (IMP). I was in charge of : ▪ Management and review of the quality documentation (CAPA, deviations, change control, batch records, internal auditing, personnel trainings, complaints, SOP, training, QAA, etc). ▪ Setting and preparation of clinical studies’ kit (batch records, creations of labels in compliance with Annex 13) and AIC documentation. ▪ Assisting the QP in her activities, including audits to suppliers, authorities and customers audits.. ▪ Procedures drawing up and implementation of SOP modules. ▪ Preparation of documents relating to the PQR (Product Quality Review), using among others techniques, Pareto analysis. ▪ Managment of the qualification activities (IQ, OQ, PQ). In the QC manager role, I was in charge of: ▪ Check the products quality, approval or rejection of incoming goods. ▪ Management of reference and retention samples ▪ Management of the temperature monitoring and pest control system. ▪ As a support to the logistic department, experience in setting and shipment management (DDT editor). ▪ Knowledge of Annex 13 (IMP), GMP. Show less



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA trainer

  • May 2015 - Nov 2015

  ▪ As a QA intern I was in charge of : ▪ Production Batch Record and logbooks review ▪ Personnel training registration and management of personnel data sheet, in collaboration with the HR office ▪ Review and updating of change control ▪ In collaboration in the analytic monographs’ management for a Global Distributor Project. ▪ Translation of technical documentation (SMF, SOP, Cleaning Validation, etc) from Italian to English ▪ Assistance during AIFA and FDA inspections and customer audits.. ▪ Use of Trackwise as a reviewer for the deviations in production (MDR), deviations in laboratory (LIR or OOS). Knowledge of ICH Guidelines and GMP. Show less



BASF

• Germany
• Chemical Manufacturing
• 700 & Above Employee

• trainer R&D and QC analist

  • Nov 2010 - Jul 2011

  Organic reactions and complete synthesis of a photoinitiator Using HPLC, GC-MS, UV-VIS, Karl-Fischer, FT-IR, reactors, thermostats, thermobalances and laboratory glassware. Organic reactions and complete synthesis of a photoinitiator Using HPLC, GC-MS, UV-VIS, Karl-Fischer, FT-IR, reactors, thermostats, thermobalances and laboratory glassware.