Michel Le Porcher

Taking charge of the quality department for the separation of quality and regulatory affairs. Management of a quality technician. Process review, process mapping, document management, quality control, quality planning, indicator management, CAPA, change management, NC management. Piloting transverse projects in collaboration with production, regulatory affairs, and support services (processes, workflow, organization).

Qualification and validation of our production equipment (fluid bed dryer, coater, press, encapsulator, thermoformer, counter...) and laboratory (HPLC, dissolution bath...) and building/premises and utilities (compressed air, purified water) according to Good Manufacturing Practices (GMP). Qualification and validation of our computerized systems. Cleaning validation and process validation. Management of a team of technicians and engineers responsible for QV (6/8 people). Support for continuous improvement and organization projects in conjunction with site management.

Management of setting sheets, backup quotation, backup manufacturing routes, improvement of production stations, design of new workstations, continuous improvement.