| CSV Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: bhavya, Avance [email protected] Reply to: [email protected] CSV Engineer Raritan, NJ Hybrid Keywords CSV, Computer System Validation, SAP Validation, ERP systems, MES, IT CSV, Manufacturing systems, Lab systems Roles and Responsibilities 2-4 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 end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology-based 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 pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement Ensures pre-executed test protocol has the necessary test data requirements to run the tests Reviews post-executed 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 -- -- Bhavya Rapelli US IT Recruiter [email protected] Keywords: rlang information technology New Jersey CSV Engineer [email protected] |
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| Tue Apr 16 20:29:00 UTC 2024 |