Chinmoy Roy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Process Analytical Technologies (PAT), Quality by Design (QbD) and Quality Risk Management (QRM).
Chinmoy offers over 30 years of US based subject matter expertise in the design, development, QA, validation and CFR 21 Part 11 implementation for automation and computerized systems. As principal Lead Engineer, Chinmoy directed several engineering teams to design, commission, validate and obtain USFDA certification for multimillion dollars worth of computerized control systems. These systems were designed to be compliant with CFR 21 Part 11 requirements and conformant to ISA’s S88 and S95 standards.
Software Design Life Cycle (SDLC) and Software Design to ISA S88 and S95 standards, Computer Systems Validation (CSV), SME, Quality Risk Management (ICH Q9), Quality Governance (ICH Q10), CFR 21 Part 11 / Annex 11, Page1, USFDA and EMEA Inspection preparation and defence, Automation systems project management and ISA SP18 Alarm Systems Management and Design
Skills & Expertise
Validation, Computer System Validation, Automation, DCS, 21 CFR Part 11, GAMP, Quality Assurance, CAPA, Engineering, Software Validation, Commissioning and SDLC
Worcester Polytechnic Institute - MSCS, Electrical Engineering and Computer Science, 1980 - 1982
Indian Institute of Technology, Kharagpur - BSEE, Electrical Engineering, 1969 - 1974