Becton Dickinson in Le Pont de claix (France)- Management of 4 analytical technicians, Analytical development and validation activities supervision, according to cGMP’s and ICH guidelines, - Technical expert and trainer on analytical validation and cleaning verification for the team (10 people), Empower® network Administrator, - Relocated for one year in Wilson NC, USA, as the R&D representative and liaison between R&D site and manufacturing site; also managed all subcontracted… Show more Becton Dickinson in Le Pont de claix (France)- Management of 4 analytical technicians, Analytical development and validation activities supervision, according to cGMP’s and ICH guidelines, - Technical expert and trainer on analytical validation and cleaning verification for the team (10 people), Empower® network Administrator, - Relocated for one year in Wilson NC, USA, as the R&D representative and liaison between R&D site and manufacturing site; also managed all subcontracted analytical activities, - Main accomplishments:• Setting up all the analytical validation documentation (strategy, SOP’s, protocols and reports templates).• Laboratory building follow up; annual budgets for equipments; Empower® network installation and qualification.• Hired 13 people, scientists and analytical technicians, to build analytical R&D and QC teams.• Highly involved in laboratory quality system building (GLP, equipments monitoring, training management).• Preparation of the first FDA inspection for Becton Dickinson (site & product). Subject Matter Expert requested during the inspection. FDA inspection passed (no 483).• Quality management: CAPA, Change Control, Deviation. Show less

Project supervision and carrying out (developments and validations), according to the cGMP’s andICH guidelines, including validation protocols and reports writing,Team technical support (12 people),Empower® network Administrator,Main accomplishments:• Online-HPLC dissolution system installation and qualification; users training; instructionsand reports writing.• Method validations ; writing of the site analytical validation SOP.