Occupandomi di progetti IT per l'automazione nel settore farmaceutico ho accumulato un'esperienza pluriennale nella gestione sia dei progetti che della qualità dei sistemi implementati. Relativamente a quest'ultimo punto, sono abituata ad occuparmi di:

• raccolta dei requisiti ed analisi dei processi
• gestione di change e CAPA 
• gestione dei rischi di progetto e root cause analysis
• collaborazione nella gestione delle procedure di qualità aziendale
• redazione di documentazione di qualità
• attività di convalida/collaudo di nuovi sistemi/attrezzature
• partecipazione ad Audit effettuati da enti regolatori e clienti

Gli altri generalmente mi definiscono una persona molto precisa e pragmatica.

Passionate to Project Management (PMP certified) and fascinated by automation, as Project Manager I managed with enthusiasm projects of digital transformation and plants revamping implementing IT solutions.
Stress-resistant and always ready for new challenges, I use to manage relationships with many partners (both providers and customers), always supporting project team and reporting to CIO and Managing Directors. All this without ever losing focus to the quality requirements of deliverables and respecting deadlines and budget.

WORK EXPERIENCES

04/05/2018 – Today
(Current job)
ICT Dept. – Project Manager, Automation and Compliance Expert
Molteni Farmaceutici
• Project Manager
• Process Business Analyst
• System Administrator of GMP computer systems
• Expert in change management for GMP systems and related Computer System Validation:
o Computer systems compliance to: 21 CFR part 11, EU-GMP Annex 11 e Data Integrity
o Support to manufacturing departments for deviations analysis detected during production
processes
o Standard Operative Procedures definition
Some important experiences:
Project Manager for Serialization Track and Trace project required by Falsified
Medicines Directive 2011/62/EU
Molteni Farmaceutici, May 2017 – September 2019
• 10 suppliers involved
• 12 National Competent Authorities involved
• 7 external partners interfaces developped
• 6 production lines impacted
• +50 end-users to train

01/03/2013 – 04/05/2018 ICT Dept. –Technical Analyst
Molteni Farmaceutici
• Project Manager (for manufacturing projects)
• Process Business Analyst
• System Administrator of GMP computer systems
• Computer System Validation execution
• Help/service desk
• Standard Operative Procedures definition
Some important experiences:
Business Analyst for SAP Implementation project (ERP replacement)
Molteni Farmaceutici, July 2016 – January 2018
• Business Analyst for QM module and LIMS interface
• ICT Responsible of Computer System Validation

01/03/2011 – 28/02/2013 Software Developer
T.I. Engineering srl
• Software development (intranet web applications and iFix SCADA)
• Writing of validation documentation for GMP computer systems
• In charge of Computer System Validation execution in pharmaceutical environment

EDUCATION AND TRAINING
10 July 2020 Project Management Professional (PMP)
PMP Number: 2780463
Project Management Institute (PMI)
April 2019 – July 2019 Master of Higher Education Management in Project Management
ISTUM Istituto di Studi di Management
• Scope management
• Schedule management
• Cost management
• Risk management
• Quality management
• Stakeholder management
• Resource management
• Procurement management
• Communication management
• Integration managemen

18 October 2018 ITIL Foundation Certificate in IT Service Management
AXELOS Global Best Practice
September 2008 Scholastic internship in ICT Dept. of AnsaldoBreda (now Hitachi)
September 2005 – June 2010 High School graduation in Computer Science:
“Perito Capotecnico Industriale con specializzazione in Informatica ABACUS”
ITIS S. Fedi – Pistoia

English B2
French A1