Profile Details

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Hire Sunny S.

India

USD 55 /hr

Freelance GCP Expert&Auditor| Expert in Clinical Quality Assurance| QA Professional with 14 yrs exp in Clinical Research

Profile Summary

Hello, I am Mr. Sunny Omkar Singh. I have over 14+ years of diverse global experience in various facets of Quality Assurance and Regulatory Affairs in Clinical Research, Pharmaceutical and Medical device industry with good working knowledge of Quality Assurance Processes, Clinical Research processes, Good Clinical Practices, Good Laboratory Practice and relevant Regulatory requirements. I am a post graduate in Analytical Chemistry from Institute of Science- Mumbai. I am also a certified Black Belt in Six Sigma from American Society of Quality (ASQ) with many training certifications like ISO 15189, 17025, GLP etc. In addition to this I am law enthusiast and hold a Bachelors degree in Law. I am experienced on national and international standards like ISO 9001, ISO 15189, ISO 13485, ISO 17025, ISO/IEC 27001, ICH-GCP, Schedule Y, New Clinical Trial Rules-2019, GLP, GMP, Drug & Cosmetic Act etc. and well-versed in handling regulatory inspection like US FDA, EMEA, CAP, NABL and other international regulatory bodies as per ISO Standards and international regulatory requirements. I carry a proven record of significant and successful contribution in quality management, regulatory affairs management, project management, vendor management and process improvement. It’s my role to perform detailed assessment of quality systems and processes to identify the problem areas and recommend improvements on continual basis, so that we can build & improve the quality systems that are appropriate for company’s stage of development. I have strategized and implemented a fully integrated Quality Assurance program and led the organization to assure regulatory compliance. Successfully managed Phase I to and IV clinical trials and Bioequivalence studies in various therapeutic areas. Keywords: Quality Assurance, Regulatory Affairs ,Clinical Trails, Medical Devices, Stem Cells, Cell Therapy, GCP,GLP Compliance, , CRO, Clinical Evaluation of Medical Devices, Bio-Analytical, Bio-Equivalence, CAPA, Root Cause Analysis, FMEA, Risk Management, Audits, Inspections, Quality Management System, Internal Audits, Risk Based Analysis, INDs, New Drug, New Devices, Vendor Qualification audits, Supplier management audits, System and Process Audits, Regulatory Compliance for Medical Devices in India, USA, Taiwan, China, Korea, Indonesia, Europe, Canada, Singapore, Malaysia and Russia.

Subject Matter Expertise

• ★ Clinical Trials
• ★ Regulatory Affairs
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ Project Management

Services

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Feasibility Study, Systematic Literature Review

Consulting Scientific and Technical Consulting

Work Experience

Sr Project Manager

Indian Council of Medical Research

January 2019 - Present

Manager-QA/RA

Totipotent RX Cell Therapy Pvt Ltd (A CESCA Therapeutics Inc Company)

December 2014 - December 2018

Assistant Manager-QA

Jubilant Generics Ltd

April 2010 - November 2014

Research Officer

Lambda Therapeutics Ltd

September 2007 - March 2010

Research Officer

Accutest Research Laboratory Ltd

June 2006 - September 2007

Education

Bachelor in Law

CCS University

June 2017 - June 2020

Masters in Science-Analytical Chemistry

Institute of Science

June 2004 - May 2006

Bachelor in Science-Chemistry

KMC College, Mumbai

June 2001 - June 2004

Certifications

• Certification details not provided.