Saumade Romain

Creation of a new unit of support (buffer and media) production:  Recruiting and training of a complete new team  SOP translation, creation and modification  Qualification and validation of new equipments  Definition of process and cleaning strategies Production activities : Autoclave, Dispensing, Buffer and Media preparation  Supervision of the day to day production and non-production activities oftheemployees.  Scheduling and allocating the resources  Participation to the deviation, investigation and CAPA  Review of the production documentation (batch record, logbooks…)

Biotech manufacturing  Working in an ATEX area, Bulk and media  Planing  EHSS deleguate since 2014  Trainer , reference for bulk and media  Equipment Qualification, Calibration and Validation.  Writing / editing protocol, report and procedure. (Tech-transfert, Stability /mixingstudy...)  Dealing with deviation and investigation  First maintenance.  Continuous Improvement (6S ...) and leading CI project  Control in process (PH, Conductivity...)

Creating a database and line setting data sheets Creating training books and training Operators Setting up improvements for packaging line and change part store

Creating drive manual for each machines  Training Operators  Setting up improvements for tablets presses, capsules machines, tablet coating  Improving cleaning room and cleaning operations

Driving tablet press (regulation, Control in process …) First maintenance (Change of die, …)

Driving packaging line (filling machine, blister machine …) Maintaining the machines