Dinesh Kumar Rajput

Background

About Dinesh Kumar Rajput

With over 16 years of experience, I'm a dedicated professional specializing in Quality Compliance within the Pharmaceutical Regulatory domain. My expertise lies in Analytical Method Validation / Verification / Method transfer and Lab investigations, adhering to the stringent requirements of 21 CFR Part 11 and GxP FDA Regulations. I have a solid understanding of GLP, cGMP, ICH, and ISPE guidelines, particularly in the context of Analytical Method Validation / Verification and Method transfer and laboratory investigations. Throughout my career, I've authored and reviewed critical documents, including validation plans, risk assessments, specifications (URS, FRS, CS), validation protocols (IQ/OQ/PQ), validation summary reports, traceability matrices, SOPs, decommission reports, and periodic review reports. My responsibilities have encompassed ensuring Analytical Method Validation / Verification and Method transfer, Lab investigations and Qualification of analytical instruments in Quality Control, following GAMP5 guidelines. I've managed the entire system life cycle documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).In addition to my expertise in validation and compliance, I've actively conducted laboratory investigations for incidents like OOE, OOT, and OOS. I've also served as a Certified Auditor for Internal and External Audits, primarily in commercial laboratories. My comprehensive skill set includes proficiency in Electronic Document Management Systems (EDMS) and Electronic Quality Management Systems (eQMS).