| Compliance Lead Position at KOP PA, USA (Hybrid) at Remote, Remote, USA |
| Email: [email protected] |
| From: Pavan Kumar, Yochana IT [email protected] Reply to: [email protected] Keywords CSV, Computer System Validation, SAP Validation, Product Serialization, DSCSA Roles and Responsibilities - 10years Experience in Validating SAP systems in Manufacturing - Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems - 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 - Good to have experience in implementing US-DSCSA Thanks & regards, Pavan Kumar, Resource Specialist, Email: [email protected] Keywords: information technology Compliance Lead Position at KOP PA, USA (Hybrid) [email protected] |
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| Tue Apr 09 00:50:00 UTC 2024 |