Chandan K. Pandey
Validation Specialist @TRUGlobal
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WORK HISTORY
Validation Specialist @TRUGlobal
Pune, IN
Responsible for CAMSTAR (MES- Manufacturing Execution System) Proofing which includes Analyzing the Redlines changes, Review and Comparison of Redlines Changes Against eDHR Workflow Report, Test Plan Preparation, Creating the work order in SAP, Staging the created work order in CAMSTAR for Proofing, Issuing the Components in CAMSTAR during proofing, Performing the Proofing for ECOs (Engineering Change Order) Changes, Post Proofing Review, Documentation and Approval in DocuSign.2. Responsible for end-to-end validations which including Preparation, Review and Execution of CSV deliverables: User Requirement Specification (URS), Validation Plan (VP), Functional Specification (FS), Configuration Specification (CS), Design Specification (DS), Functional Risk Assessment (FRA), Installation Qualification (IQ),(IQSR), Operation Qualification (OQ),(OQSR), Performance Qualification (PQ),(PQSR), Traceability Matrix (TM) and Validation Summary Report (VSR).3. Responsible for Understanding & analyzing the Business and functional requirements for application.4. Responsible for accurately maintaining and updating the Daily Status Report (DSR) using both the DSR Tool and JIRA.5. Knowledge of IT Change management Tool such as ServiceNow (SNOW) to raise the change request for SAP system and Non-SAP System, Bug tracking tools such as JIRA.6. Define, strategize, coordinate, and gather information necessary to facilitate comprehensive testing activities.7. Effectively coordinate with multiple resources throughout the testing lifecycle.8. Validation of electronic Device History Records (eDHR) reports and other configuration reports.9. Collaborate closely with the development team across multiple platforms and other cross-functional teams to identify acceptance or production issues, ensuring thorough retesting of fixes for effective resolution.10. Engaged actively in client meetings and provided user assistance.
ABOUT CHANDAN K. PANDEY
A forward thinking, capable and committed CQV (Commissioning, Qualification and…
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