Lisa Romei

Csv Csa & Data Integrity Specialist @PQE Group

Firenze, IT

Data integrity management at GSK Vaccines Siena and Rosia sites. Use of SAP PM for GMP and non-GMP equipment calibrations. • Direct collaboration with all the company departments • Support during AIFA and FDA inspections. • Collaboration with QA department for DR, CAPA and Change• Implementation of new internal work management processes resulting in cost savings, reduction of wasted resources and optimization of document flow.Drafting of IQ, OQ protocols and reports for instrumental qualifications in Pzifer, Teva, Menarini, FIS and SIFI. Performing gap analysis for Stevanato Group. Validation support for IT infrastructure Resiliency Tests and CSV tests for 30 Takeda sites. Infrastructure Qualification management and supervision of IT team on Planning and preparation; Risk Assessment; Design Specification; Testing Writing and maintaining the IT SOPs.