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Dhamodharan Durai

Dhamodharan Durai

Computer System Validation

Education / Training

Ambattūr, Thiruvallur

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Services offered

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.

Computer system validation
Audit management
Quality assurance
Pharmaceutical industry
Training management
Regulatory compliance
Approximate rate: ₹ 400 per hour

Experience

  • 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.

Education

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

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