Dr. Davide Valenti

The role comprises all the aspects related to audits and inspections. During the stay at the sites I am the reference for lead auditors, inspectors and their teams in order to provide them with answers belonging to GMP processes and activities carried out by the CDMO

During my stay at the Arvato's Italian site I was hired as responsible person; my activities comprised the creation of the entire local QMS in accordance with the global European one. Furthermore I was involved in those typical GxP activities affecting the product quality i.e. training, management of deviations and CAPA, complaints and recalls, creation of SOP, audits and self inspections, management of Italian traceability system ("bollini" system) in conjunction with Italian MoH

Arvato SCM Healthcare is a global depositor with a manufacturing license for secondary packaging activities, thus as Quality Assurance Manager within such a company I was involved in all of the following typical GxP activities: -Check of batch documentation (CoC, CoA) -Creation of Master Batch Record -Management of returns, complaints and recall according to GxP guidelines -GMP training -Management of deviations and CAPA

As part of the Arvato's pharmaceutical back office department I was involved in all the Order to Cash activities like: -Management of end customer orders -Management of returns -Management of credit and debit notes Contacts with end customers and MAH (Marketing Authorisation Holder) -Contacts with local MoHs

During my stay at Arvato Direct Services GmbH I worked as member of the Microsoft Regional Service Center in order to assist and advise the Microsoft partners in their Partner Network membership. Furthermore I worked as Microsoft license expert to advise the reseller in purchasing the correct licenses for several different network (failover clusters; load balancing cluster; VDIs)

Advisory and sale of pharmaceutical products Nutrition advisory and diet planning

During my stay at Herbeka s.r.l. I was involved in the production of solid, semi-solid and liquid dosage forms; the carried out activities were: -Setup of machines and lines -IPC -Creation of Batch Records -AQL tests

Advisory and sell of food supplements

Management of bank credits toward debtors

German qualification for the Profession of pharmacist

Enrollment in the german pharmaceutical professional association

Enrollment Italian Pharmaceutical Professional Association

Italian qualification for the Profession of pharmacist

Master of Science in Pharmaceutical Chemistry and Technology