Italy
I have 10 years of experience in the pharmaceutical industry, always in close contact with Quality and Production enviroment. I am curious , oriented to result, problem solving and proactive collaboration with a strong focus on continuous improvement. I have acquired over the years high experience in: quality assurance and process knoledge in packaging and aseptic department ,project management for local and network project , the implementing of MES systems (eBR in different software ), project team coordination, inspections (AIFA,FDA and internal), documentation management (autor, reviewer, approver), data integrity, validation and change management. In addition, I have experience and passion for techlology, digitization, and systems that can provide quality and production benefits for a manufacturing site. Actually i Lead a MES implementation project on secondary
Lead of MES (Siemens) Implementation at secondary level Coordinator of ebr designer team ( 8 people) LBO MES Designer for Power App, Power Automate and PowerBi Site Trainer for digitaltool
QA Approver of Aseptic Change Request Lead of Continuous improvement project on CRs at site level (with Kaizen Facilitator Certification ) QA Validation Approver (URS, PQ, RIOQ ) QA approver in MES implementation project (Siemens) Support Internal and External Inspections Lead of Improvement Departmental Archive Creation of an app in Powerapp
During this period I was involved in various projects at site and network level both as project leader(PL) or QA major stakeholder(MS): New product tech transfer project (network, MS) New In Process Control (IPC) approach to replace AQL (network, MS) Paperless Project leader (dept.,PL) "Campaign mode" project (dept., MS) ROPALOG project related to process logbooks (dept., PL) New EBR validation approach ( electronic only, dept., PL) Coordination and management EBR implementation on two new Packaging lines Line Clearance and Serilization projects in EBR (dept.,PL) Data integrity Member Trainer
MES Designer and QA Approver " for Pas-X system of Werum Management, analysis and improvement of department KPIs Gemba activities in the department Qualification of Change Owner (CR) Qualification of Deviation Owner (DR) Trainer OJT for new colleagues (3 people) Management and preparation for FDA and AIFA inspections
Shift work in the QA Shop Floor of packaging department (3x5 shifts, h24, 11 Lines) QA Reviewer and Approver in MES system, Werum Pas- X Quailification of SAP BPE (Business Process Expert) and QA data owner for SAP codes Author ,Reviewer and approver of procedure Managing Deviations and CAPA Management of departmental KPIs Qualification of Department Trainer
Pharmacist with relationship with the public; Acquisition, holding and dispensing of drugs; Preparation of drugs in galenic laboratory;
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