Roy Cherris

Managing Partner - Pharmaceutical Microbiology, Visual Inspection and Validation Consulting @Bridge Associates International

Princeton, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 1998 — Present

Managing Partner - Pharmaceutical Microbiology, Visual Inspection and Validation Consulting @Bridge Associates International

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Princeton, DE

Roy\'s consultancy role is to assess and provide guidance is all areas of regulatory compliance with a focus on the microbiological control and monitoring aspects of parenteral, topical, ophthalmic, liquid, solid dose and medical device manufacturing. He is a well respected expert in the field of visual inspection systems and investigative microscopy for particle source identification and mitigation. He also specializes in the physical characterization of excipients, bulk drug substances and primary packaging components as they apply to pharmaceutical development, clinical and commercial manufacturing. His technical expertise includes visual Inspection, investigative microscopy, aseptic manufacturing, sterilization processes, environmental monitoring, microbiological testing, medical devices, laboratory and process development, as well as the qualification of equipment, facilities, and instrumentation. He has been certified by the New Jersey Pharmaceutical Quality Control Association in GxP, Good Manufacturing Practices. He has extensive experience with the validation of software, computerized control systems and metrology systems. Roy has worked internationally throughout the Americas, Australia, Europe and Asia.

SKILLS

LimsMicrobiologyLife SciencesQuality SystemV&VCleaning ValidationSoftware DocumentationTechnology TransferChange ControlCapaQuality ControlGmp21 Cfr Part 11BiotechnologyStandard Operating Procedure (Sop)GxpAseptic ProcessingIso 13485Regulatory RequirementsValidationU.s. Food and Drug Administration (Fda)Regulatory AffairsLifesciencesPharmaceutical IndustrySopFda

ABOUT ROY CHERRIS

InQuest Science-Defect Control Systems and Bridge Associates International-Consulting

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Roy Cherris — Managing Partner - Pharmaceutical Microbiology, Visual Inspection and Validation Consulting at Bridge Associates International in Princeton, NJ, US | Unifers