Jerôme ARDISSONE

Jan. 2010- Today

Global Quality Compliance Auditor:
• Audits of APIs suppliers, 3rd party Finished Dosage Forms manufacturers, Packaging and Laboratories contractors
• Audit reports redaction and CAPA plans follow up

Dec. 2006 - Dec. 2009
 Quality Officer (Retail Market):
• Mylan SAS retail market products management: GMP compliance, batches releasing, complaints, change control, stabilities, annual product reviews, packaging articles rebranding, Third Parties importation compliance
• Subcontractors audits on oral solid dosage forms sites, API manufacturers and distribution plants and audits reports redaction
• IT QA interface: Carve Out project, SAP’s projects, Genesis (regulatory software)

Oct. 2005 – Dec. 2006
 Validation Manager:
• Equipments Qualification (QC, manufacturing, packaging, utilities) and Validation of processes management
• Team management (4 persons)
• FDA and European Health Authorities Inspections preparation
Sept. 2004 – Sept. 2005
 QA representative in Manufacturing Dpt:
• FDA agreement preparation: internal audits training / CAPA / cGMP compliance
• Technology Transfer Project: writing of validation processes documentation
• Equipments qualification (IQ, OQ, PQ)