Representative Profile of our Information Technology Compliance Auditor

Has 14 years of quality assurance, compliance and validation experience in Pharmaceutical and Information technology. His Pharma Industry experience includes Computer System Validation for global and site-specific systems, Equipment Validations and exposure to Regulatory Inspections i.e. US FDA, UK MHRA and ANVISA – Brazil. While working as a Life Sciences domain consultant at IT majors, he is instrumental in building compliance practices at offshore (India) and responsible for quality, delivery of the projects, practice growth & competency building.

He is experienced in working with cross culture global team(s) across USA, Europe and Asia. He is proactive in collaborating with business unit leaders in managing projects to improve systems. In assignments for Pharmaceutical majors as a consultant he has played multiple roles of IT risk and compliance manager and Program quality manager responsible for process and regulatory compliance of operation and services.

 

Other key personnel include:

• Mr. Bipin Patel, Director
• Mr. Hitesh Shah, Director
• Representative Profile of our GMP Compliance Auditor