CSV Engineer - Katalyst Healthcares & Life Sciences

Responsibilities: 3+ 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.