Gilead Sciences

San Francisco Bay Area United States

Medical / Health Care / Pharmaceuticals

A world renowned and accomplished Pharmaceutical,Biotechnology and Medical device GXP Consultant with a record of getting things done in the following areas: 1.New Product Design and release 2.Process validation 3. Change control: use of Quality Risk Management and Risk assessment 4.Process control: Process validation,SPC and Robust process design through QbD. 5.Consent decree ,warning letter,and 483 resolution 5.Process design:use of QTP, QbT, CQAs and Design Space 6.GxP Training:Process validation, Change control,CAPA and supplier Quality Management 7.Quality system audits 8.Supplier evaluation and Qualification 9. cGMP training 10.Sterilization. 11. USP water system installation and i...