Beatrice Preda

Quality Compliance Specialist @Delpharm

Milano, IT

Review and approve technical documents (e.g. Master Batch Records, Analytical Methods, Process Validation protocol and report, etc.) to ensure compliance with product dossier; Check CTD Module 3 to assess the potential regulatory impact of internal Change Controls; Manage paper-based inspections from Health Authorities; Support in managing HAs and Clients on-site inspections; Support clients with regulatory requests; Manage applications and notification to AIFA (e.g. GMP Certificates, Certificates Pharmaceutical Products and “Modifiche essenziali e non essenziali”); Perform internal and external audits; Supplier management; Discuss Quality Agreements with Customers and Suppliers.

Liceo Scientifico Statale A. Einstein

Diploma di scuola superiore

Università degli Studi di Milano

Laurea Magistrale LM