Bulle, Fribourg, Switzerland
Manage, train and develop a team of 12 manufacturing technicians working in 3*8 shifts in Pharmaceutical Production. Lead the operations processes to deliver compliant and robust Film Coated Tablets batches
Responsible for defining and leading process improvement in case of process change, technology transfer and equipment change (Solid Oral Dosage Form). Lead the investigations and manage the deviations / complaints / CAPA and change control required Implementation of the Continued Process Verification (CPV) for all the Drug products manufactured in Pharmaceutical Production (4 Drug Product) with Discoverant® software (Data management & Statistical software). Lead the process validation and the cleaning validation Participate to GMP inspections (FDA, Swissmedic) and partners/clients audits.
Lead, coach and develop the performance of the team (5 engineers) and manage/develop the clients relationships Define, coordinate and execute equipment Commissioning/Qualification (C&Q) and process validation activities following traditional or QbD approach Project Management (quality and performance improvements) Activities performed as a consultant for the following clients in France and Switzerland: Baxter Neuchatel (Sept 2013-Oct 2015), Novartis Animal Health Huningue (July 2012-July 2013, Genethon Evry (April-June 2012), Sanofi Pasteur Val de Reuil (Jan 2011-March 2012), Baush & Lomb Aubenas (Nov 2010-Jan 2011), Schering Plough Caen (April-Nov 2010)
Optimization of the sterilization processes in the Fill Finish Building (equipment flows, autoclave cycle optimisation, Performance qualification)