Mr. Bipin Patel, Director

Mr. Bipin Patel is a qualified Quality Assurance professional with 15 years of work experience working in US, European and Indian pharmaceutical industry. As Director, he is responsible for overall quality operations at RS Serve.

His specialties include: 



• GCP audits (lead more than 300 audits of clinical investigator sites, TMFs, study documents and third party vendors (including Clinical laboratories, CROs, Drug depots, Phase I Units, Bioequivalence/Bioavailability Units (including Bio-analytical labs), Translators and Ethics Committees)
• Pharmacovigilance system audits
• Data Management audits (including clinical database audits and process audits)
• Statistical programming and Clinical Study reports audits
• Computer System Validation audits
• Developing and implementing risk based Quality System plans
• Inspection readiness planning and conducting mock inspections
• Handling serious quality issues, leading for cause investigation, Root cause analysis and CAPA management
• SOP development
• Customized GCP training and auditors’ skill development audits.

Bipin has lead GCP audits in India, Australia, Japan, Malaysia, Philippines, Singapore, South Africa, South Korea, Thailand and Vietnam. He uses his global expertise and multi-cultural exposure to provide services to clients in the health sciences industry with their requirements in India and the Asia-Pacific region.

He has successfully faced regulatory inspections (and has lead inspection readiness program) from DCGI – India, UK MHRA, US FDA, EMEA, Taiwanese FDA, Vietnamese MoH, South Korean FDA, ANVISA – Brazil, WHO, MCC – South Africa and Israel – MoH.

A pharmacist by qualification, he holds a Masters in Pharmacy degree (with specialization in Quality Assurance) from Gujarat University. Bipin started his career in the year 2000 and has worked in multiple roles related to Quality Assurance in Torrent Research Centre (India), Wellquest Clinical Research (India), Pfizer Development Operations (India), inVentiv Health Clinical (India and Singapore) and Servier Singapore Pte. Ltd.

 

Other key personnel include:

• Representative Profile of our Information Technology Compliance Auditor
• Representative Profile of our GMP Compliance Auditor