Smitha Marneni Email & Phone Number

• Over 12 years of experience in Information Technology with emphasis on SDLC, QMS, Computer System Validation (CSV) Life Cycle, 21 CFR Part 11, 210/211 validation, Good Testing Practices, Good Documentation Practices (GDP) and GAMP software categories.• Expert in Computer software system implementation and validation in compliance with FDA cGMP regulations and GAMP standards.• Hands-on experience in QA review of different validation documentation such as Compliance Plan, Requirements, Risk Assessment, Design documents, Test Plan, Test Scripts, Test Summary Report, Traceability Matrix and Compliance Summary Reports for projects.• Generated Compliance Plan, Risk Assessment, Traceability Matrix and Compliance Summary Report for Projects.• Experience with pre and post review of validation test scripts assuming a quality and compliance role based on the Business Requirements, Functional Requirements and Design Specifications for the Functionality, Security, System, Regression, Integration and User Acceptance Testing (UAT). • Experience with testing tools HPALM, qTest and JIRA. Involved in Test Management, Defect Tracking, Defect Management. • Experience in reviewing SOPs/WIs related to the systems supported.• Strong knowledge of incident management, CAPA (Corrective and Preventative Action) and Non-Conformance (NCs) processes and Data Integrity. • Engaged in project meetings and provided quality and compliance guidance on project related activities.• Quality and compliance validation experience on SAP.• Quick learner with strong project management, analytical and communication skills.

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  Computer System Validation Engineer

  Johnson & Johnson