Industrialization Expert
CurrentTranslating R&D designs into manufacturing products according to technical requirements, quality levels, project plan and budget. Main activities include:- Feasibility testing of new IVD products, designing experiments, follow-up with lab technicians interpretting results, approving reports, identifying risks.- Assess incoming materials: quality, stabilty, chemical and manufacturing compatibility, chemical and biological safety- Develop stability strategy in compliance with national… Show more Translating R&D designs into manufacturing products according to technical requirements, quality levels, project plan and budget. Main activities include:- Feasibility testing of new IVD products, designing experiments, follow-up with lab technicians interpretting results, approving reports, identifying risks.- Assess incoming materials: quality, stabilty, chemical and manufacturing compatibility, chemical and biological safety- Develop stability strategy in compliance with national and international (CE, FDA, PMDA) regulatory requirements and other applicable guidelines.- Proposes, develops and validates QC methods, including transfer to operations- Assess risks for product materials, product design and manufacturing processes - Event management in case of NCR, Issues and CAPA during product life-cycle- Conforming to legislation & regulations ISO13485, IVD R directive, ISO14971, 820 CFR, GxP (e.g: GLP, GMP, GDP)- Process owner: responsible during audits and training of personnel Show less