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Arijit Das Gupta

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A result oriented pharmaceutical professional with 11+ years of rich experience in Development Quality Assurance, Analytical Quality Assurance and Analytical Research functions. I am an ISO 9001:2015 Certified QMS Lead Auditor with skills of handling regulatory inspections including MHRA and USFDA and answering the queries raised by regulators. I carry hands-on experience of new lab setting as per USFDA requirements which include implementation of Quality Management Systems (Change Control, Deviation, OOS etc.), Quality Risk Management, Qualification of Analytical Instruments, Computer System Validations. I possess thorough knowledge of 21 CFR Part 11 and Data Integrity requirements by USFDA and MHRA. Over my career span, I have garnered expertise in Development QA, Regulatory Inspections, Analytical Research, and Abbreviated New Drug Application (ANDA). I have been instrumental in conducting Internal & external audits and review of documents related to instrument qualification, standard test methods & specifications and Protocols/reports related to Analytical Method Development, Method Validation, Method Verification, Method Transfer, Cleaning Validation and Stability Study.

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