Dhamodharan Durai

Overall 9 years of experience (7+ in pharma industry & 1+ in Research Lab). Looking for CSV (VLMS, ComplianceWire), Handling of QMS, APQR, CPV, QRM & MRM, Internal Audit, Customer Audits, Compilation and responding to regulatory agencies, Lean Six Sigma, Supplier Quality Management, Training Management, Audit trail review.

• QA reviewer for SAP, LIMS, Ample-logic for QMS etc.
• Software Development Life Cycle, Technical Writing, performing, and testing in the Pharmaceutical industries including specialization in 21 CFR part 210,211 compliance and GAMP, GxP’s (GMP, GLP and GCP).
• Good working experience with LabWare LIMS software involving tracking raw materials and samples, modeling work flows, managing data collection and reporting and communicating this information to corporate systems, end users.
• Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA.
• Reviewer of Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification – OQ, and         Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM).
• Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Performed GAP analysis in identifying compliance gaps.
• Developed and implemented corrective action and preventive action plans (CAPA).
• Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Very proficient in writing Validation Summary Report (VSR) and Test Summary Report (TSR).

Specific Projects Implemented – VLMS, e- Logbook (ValGenesis) ComplianceWire IC (Chromeleon), Water System (Simatic WinCC, Pharmalab) etc.

B.Tech (Biotechnology) and MS (by Research)