I'm a Senior Quality Assurance Officer with a solid background in the Healthcare and FMCG industries and a licensed Pharmacist in Italy. Over the years, I've gained hands-on experience in different areas, i.e. manufacturing, Supply Chain and Regulatory Affairs. Each of them have shaped my ability to adapt quickly, stay resilient and lead with a clear focus on value. Today, I work within a multicultural team, supporting Quality across SouthEast Europe. I truly believe that diversity and collaboration are key drivers of innovation and sustainable growth. My leadership style is grounded in Lean thinking. I’m passionate about driving continuous improvement, optimizing processes and empowering cross-functional teams to deliver real value. I approach projects with a critical eye, aiming to reduce complexity, eliminate waste and enhance efficiency without losing sight of the people involved. I see Quality not as a checklist but as a mindset. It's about doing what's right—even when no one is watching—and creating a culture where excellence becomes second nature.
- Quality Management System SOPs: Authoring and updating Standard Operating Procedures (SOPs) to reduce complexity and eliminate waste. - Risk & Change Management: Driving cross-functional Risk Assessment and Change Management initiatives to support business growth while maintaining strict regulatory compliance and product quality. Deviation & CAPA Governance: Managing and investigating deviations, implementing robust Root Cause Analysis (RCA) and CAPA plans; leveraging data trending and KPIs to proactively prevent recurrence and streamline processes. - Digital Systems: use of TrackWise, VeevaVault, and PowerBI as key tools for quality tracking. - Training & Quality culture delivery: designing and delivering impactful training programs to foster a "Quality mindset" culture across multicultural teams.
• Maintaining and processing of the local regulatory database; • Submission of the required documentation to the Health Authorities in order to ensure products placement on the market according to Italian and European legislation (i.e. medicines application for variations and renewals, etc.); • Support the team in Advertising and Promotional activities approval in compliance to regulatory requirements and medical content (submission to the Health Authorities); • Artwork revision and approval; • Parallel imports; • Regulatory Intelligence activities: analysis of the competitor scenario and market share; • Support the DSO for PhV activities: AE reporting, scientific literature revision, follow-up AE and consumer relation.
- Process Performance and Product Quality Monitoring: data collection (SAP M-ERP system), trend analysis and process capability (STATISTICA 12™), root causes analysis; - Data Trending for Continued Process Verification activities (PPA Dashboard); - Product Quality Lifecycle Management: Product Control Strategy (PCS) – CQAs, CPP and ICP; - Drafting of Documents (Technical Reports, Product Quality Reports, CPV Data Trending log, etc.); - GMPs of Sterile Medicinal Products, Eudralex Volume 4 - Annex I; - Knowledge of the Production Process of Injectable Antibiotics.
Arrangement of OTC drugs and ethical drugs, monitoring products expiring date, checking prescriptions destinated to NSS, updating registers, recognizing differences between branded and unbranded drugs, checking electronic register to control drugs supplies and availability, etc.