Etindranadh Paruchuri

Background

About Etindranadh Paruchuri

Experienced in Salesforce.com Responsible for ensuring the implementation of regulated systems on Cloud Platform comply with follow Computer System Validation standards in terms of GAMP 5 guidelines, organizations CSV Process with knowledge of FDA 21 CFR regulations, Annex11, Good Documentation Practices, Good Testing Practices, Change Management Process Hands-on experience in authoring and updating Requirement Trace Matrix, Validation Plan and Validation Summary Reports Train users on Validation Methodologies, Quality Systems, GDP practices Worked on the Periodic Reviews, GAP Assessments and Remediation Activities Change Management for General, emergency, patch releases and system upgrades Ability to analyze and verify requirements (UFRS), Risk assessment (SRA, FRA), traceability (TM) documents. Responsible for review and approval of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts Worked on Deviation, Defect management and Project change management Interaction with customer to clarify process/validation related queries during audits and/or in project implementation phase Good work experience in using JIRA, HP ALM, AzureDevOps and ValGenesis Involved in the internal audits like Process, Delivery Audits Involved in the external audits like ISO 13485 and Due Diligence Worked on Qualification of Mainspring, JIRA with Xray Test Management Tool to eliminate the paper-based execution