Rikin Bhavsar

Background

About Rikin Bhavsar

1) Result oriented professional with 19 years of experience in Quality Assurance. 2) Skilled with specifics oriented towards Quality Systems and Operations in GLP, GCLP, GCP & CSV. 3) Proficient in developing & streamlining systems with proven ability to enhance effectiveness and meet business goals for business excellence within the timelines & quality parameters. 4) Experienced in deploying and executing Audit plans & SOPs for overall management, supervision and implementation of Quality Systems. 5) Had played a dynamic role in the QMS set-up for Enem-Nostrum-CRO, Navi Mumbai. 6) Had efficiently and effectively managed QA deliverables during the COVID-19 pandemic by Hybrid work dynamics. 7) Have successfully hosted 40 Regulatory Inspections from Different potential Regulatory Authorities.(i.e. DCGI, USFDA, MHRA, WHO, ANVISA, NPRA, AGES, EMA, KAZAKHSTAN) 8) Have responded to more than 695 Regulatory Queries received from different regulatory Authorities. 9) Have led and executed 1800+ Study Audits.