CRX LIFE SCIENCES - Key Persons
Brijesh Patel - Chief Compliance Officer
Brijesh Patel, "Brij," is the co-founder & CCO of CRx Life Sciences. Brij has more than 10 years of consulting experience, and 20 years of validation, engineering, and project management expertise in life sciences industries.
He has served as the Validation/CAPA Project Lead, Process Development Lead, Senior Compliance-Quality-Technology Consultant, Validation Specialist/Engineer, and Analytical Chemist. He has extensive working knowledge of IS013485, IS014971, IS09001, MDD93/42/EEC, cGMP, GXP, GAMP, 21 CFR Part 11, 210, 211 and 820 compliance.
Brij has more than 10 years of consulting experience, and 20 years of validation, engineering, and project management expertise. He has extensive knowledge of quality standards and regulations pertaining to the life sciences industries.
Job Titles:
- Chief Executive Officer
- President
Hoyt Randall Smith, "Randy," is the co-founder, President, & CEO of CRx Life Sciences. Randy has more than 20 years of consulting experience, and 35 years of executive management, engineering, and program management expertise in life science, and diverse industries in both domestic and international settings. He has served as the VP of Operations, Manufacturing Site Manager, Director of Quality & Program Management, Quality Manager, Manufacturing Manager, and Process & Product Development Manager.
As a certified independent third party auditing contractor, he has audited compliance to ISO13485, ISO14001, ISO9001, TS16949, and QS9000. He has fully installed Quality Management Systems and Environmental Management Systems for many companies who then successfully received ISO certification.
Job Titles:
- Chief Operating Officer
- Co - Founder
Shital Patel is the co-founder and Chief Operating Officer (COO) of CRx Life Sciences. Shital has more than 12 years of consulting experience, and 18 years of project management, engineering, validation and compliance expertise in the pharmaceutical and medical devices industries, spanning both start-ups and Fortune 500 corporations.
She has held positions of increasing responsibility by leading risk reduction efforts within manufacturing environments by ensuring conformance to established control mechanisms for quality systems excellence in the areas of Validation, CAPA, Risk Management, and Design Control. Shital is a subject matter expert in ISO13485, ISO14971, ISO9001, MDD 93/42/EEC, FDA21CFR Part 820, FDA21CFR Part 11 and other standards (domestic and international) relevant to the medical devices and pharmaceutical sectors.
Shital received her Bachelor of Science degree in BioEngineering from the University of Illinois.
Shital has more than 12 years of consulting experience, and 18 years of project management, engineering, validation and compliance expertise in the pharmaceutical and medical devices industries including start-ups and Fortune 500s.