CSV Engineer

Keywords :

CSV Computer System Validation SAP Validation ERP systems MES IT CSV Manufacturing systems Lab systems

Roles and Responsibilities :

• 24 years Experience in Validating MES or Manufacturing an Lab systems
• Experienced in CSV activities in Manufacturing related applications like SAP Systems MES systems or Lab related systems in the manufacturing space
• Perform review for GxP systems to ensure compliance with regulatory requirements
• Working knowledge on endtoend validation of GxP applications and is able to perform document/process Compliance Analysis
• Adept with Agile and Waterfall methodologybased software development Compliance and has prior experience in Computer System Validation using Agile methodology
• Reviews Requirement Specifications Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability
• Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements
• Performs review of preexecuted test protocol which includes all the basic elements of a test script completeness and appropriateness of the test case to the requirement
• Ensures preexecuted test protocol has the necessary test data requirements to run the tests
• Reviews postexecuted test protocols for the completeness accuracy of the results and evidence and enables team on the defect management process
• Able to author Validation Plan and compile Validation Summary Report and generates RTM
• Reviews and ensures that the Operational Procedure for the application is ready
• Is able to handle Change Requirement related implementation for small changes responsible for Implementation Plan Impact Assessment Test Plan/ Results Defects and RTM

Prior experience in using tools like ALM DMS and JIRA