Shamim Chowdhury

Shamim has over 18 years of domestic and international experience in pharmaceuticals, biologics and medical device industries. In his current position, Shamim provides a full range of risk-based GMP consulting services primarily in areas of Quality Systems Regulation (QSR), Regulatory Compliance, Regulatory submissions, and Risk Management. He also provides Quality oversight and Global Project Management services. Shamim has extensive international travel and work experience with clients in Europe, India, Asia-Pacific and Puerto Rico.

Work Experience

Shamim focuses on project governance and execution for successful delivery of client projects while concurrently providing thought leadership and subject matter expertise to his clients. His projects have ranged in scope from small startup and new facility approval to Quality System, compliance and Validation remediation activities at multisite, global Pharmaceutical, Medical Device and Biologics firms. Specific activities have included GMP Assessment of Manufacturing Facilities and Quality Systems, Compliance Audits for drug and device manufacturer, mock-PAI, Data Integrity Audits and Training, Validation Program Re-design and Implementation, FDA Consent Decree, Warning Letter/483 Response, remediation support and management.

Prior to his current role as a Senior Director, Shamim worked as a Manager at Parexel’s Integrated Product Development (IPD) Group where he provided regulatory strategy and new drug development support for PC clients. Prior to joining Parexel, he held a position in industry as a Validation Engineer at Abbott Laboratories Diagnostic Division.

Education

Shamim holds a B.S. degree in Chemical Engineering from Illinois Institute of Technology. He is also Industry Certified as a: Project Management Professional (PMP) and Regulatory Affairs Certified (RAC).