Samit Chatterjee
Senior Consultant at Brevitas | Toronto, Ontario, Canada
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Samit Chatterjee serves as the Lead Consultant for Computer System Validation (CSV) at Brevitas Consulting, where he leverages over seven years of specialized experience to drive transformative change in the bio/pharmaceutical sectors. His expertise lies in the meticulous planning, assessment, and validation of complex analytical and manufacturing systems, as well as automation software, ensuring compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). Samit’s role is pivotal in delivering tailored solutions that meet the stringent quality requirements of both brand and generic manufacturers.
At Brevitas Consulting, Samit has successfully led key projects that involve the development and execution of comprehensive risk assessment and remediation plans. His proficiency in authoring CSV protocols, traceability matrices, and Installation Qualification/Operational Qualification (IQ/OQ) documentation has established him as a trusted partner for clients navigating the complexities of regulatory compliance. His deep understanding of GAMP-5 guidelines and data integrity principles ensures that the systems he validates not only meet regulatory standards but also enhance operational efficiency.
Samit’s diverse skill set encompasses a wide range of methodologies and technologies, including process validation, microscopy techniques, and biochemistry applications. His hands-on experience with analytical test devices and production equipment positions him as a leader in quality operations validation. By fostering strong relationships with external partners at the CxO level, Samit drives strategic initiatives that enhance quality management systems, ultimately contributing to the success of his clients in the highly regulated pharmaceutical landscape.
Senior Consultant at Brevitas in July 2024 to Present
Quality Operations Validation Systems (QOVS) Manager at Resolute Workforce Solutions (subsidiary of Brevitas Consulting Inc.) in March 2018 to June 2024
Lead Consultant - Computer System Validation at Brevitas Consulting - Inc. in March 2016 to September 2023
Commissioning and Qualification Consultant at Brevitas Consulting - Inc. in January 2016 to July 2016
Business System Analyst / Validation Specialist at Brevitas Consulting - Inc. in July 2015 to November 2015
Senior Consultant - C&Q at Brevitas Consulting - Inc. in April 2013 to July 2015
Postdoctoral Research Fellow at University Health Network in January 2006 to January 2012
Postdoctoral Associate at Weill Cornell Medical College in September 2001 to May 2006
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National Centre for Biological Sciences (NCBS), Ph.D., August 1995 to August 2026
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Quality Assurance
Manufacturing Process Data Integrity
Pharmaceutical Quality Control
Pharmaceutics
External (CxO) Partner Quality Management
Functional Risk Assessment and Remediation Plan
Periodic Reviews (Performance, Validation, Compliance) of Test Methods
GAMP-5
Design Qualification
Requirements Traceability
Data Integrity
Quality Management Systems (QMS)
Commissioning and Qualification
Project Management
QC Test Method Validation
Electronic Document Management System (EDMS)
Communication
FDA GMP
Computer System Validation
IQ, OQ, DQ, commissioning protocol development
IQ, OQ, DQ, commissioning protocol execution
Good Documentation Practice
Cell
Cell Culture
PCR
Cell Biology
Protein Chemistry
qPCR
Biochemistry
Microscopy
DNA
Molecular Biology
Tissue Culture
Assay Development
Three-dimensional cell culturing and microscopy
RNAi
Cancer
FRET microscopy
RNAi library subcloning
Life Sciences
Data Validation
Process Validation
Regulatory Requirements
Global Regulatory Compliance
Western Blotting
Biotechnology
Analytical Skills
Problem Solving
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Discover more about BrevitasWhat is Samit Chatterjee email address?
Email Samit Chatterjee at [email protected]. This email is the most updated Samit Chatterjee's email found in 2026.
How to contact Samit Chatterjee?
To contact Samit Chatterjee send an email to [email protected]. (updated on October 11, 2024)
What company does Samit Chatterjee work for?
Samit Chatterjee works for Brevitas
What is Samit Chatterjee's role at Brevitas?
Samit Chatterjee is Senior Consultant
What is Samit Chatterjee's Phone Number?
Samit Chatterjee's phone (416) ***-*783
What industry does Samit Chatterjee work in?
Samit Chatterjee works in the Pharmaceuticals industry.
Samit Chatterjee Email Addresses
Samit Chatterjee Phone Numbers
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