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Nicola Bocchini Parolini
Glp Unit Manager - Gmp Compliance Advisor & Auditor - Pqe Associate Partner @PQE Group
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WORK HISTORY
Glp Unit Manager - Gmp Compliance Advisor & Auditor - Pqe Associate Partner @PQE Group
Milano, IT
PHARMA COMPLIANCE CONSULTANT - QUALITY ASSURANCE EU and US GMP, GLP, GCLP & GDP RegulationsGMP and GDP Compliance:o FPF and API (Sterile and no-sterile products)o Lead Auditoro Preparation, assistance and response of regulatory inspections (US and EU)o Sterility Assuranceo Quality Risk Managemento Quality events and CAPA managemento Editing/Review of Quality Documentation, SOPs and Work Instructionso Batch Record Review and Issueo Process and Cleaning Validationo Suppliers Qualification and QTAo Cross Contamination Preventiono Continuous improvemento Annual Product Review / Product Quality Reviewo Change Control Managemento Sampling and Stability Product Managemento Warehouse Managemento Transports/Shipping Validation o Trainingo Data integrity and ALCOAGLP and GLCP Compliance:o Lead Auditoro Review and Approval of GLP/GLCP Study Protocol, Amendments and Reporto Raw Data Reviewo QA Statement releaseo Facility, process and study based inspectionso GLP and GCLP Studies Audit (in-vitro and in-vivo)o QMSo Documentation and Samples Archiving Medical Device compliance:o ISO 13485 and ISO 14971o Medical device reportingo SOPs and Work Instructionso Technical File issue and approbationo Risk Managemento Traceability o Label approbationo Italian registration
EDUCATION
Università degli Studi di Ferrara
Laurea specialistica, Biologia Molecolare
Università degli Studi di Padova
PhD - Dottorato di Ricerca, Tossicologia
Università degli Studi di Padova
Laurea Triennale, Biologia Molecolare
Università degli Studi di Verona
Master Universitario, Farmacovigilanza e Discipline Regolatorie del Farmaco
ABOUT NICOLA BOCCHINI PAROLINI
GLP Unit Manager - GMP Compliance Advisor & Auditor - PQE Associate Partner
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