TechDigital Group
Overview
Job details describe a role requiring extensive experience in validating systems and GxP-related applications, with responsibility for reviewing GxP systems to ensure regulatory compliance per customer SOPs. The position involves end-to-end validation of GxP applications, with document/process compliance analysis and familiarity with Agile and Waterfall methodologies. Responsibilities
12 years of experience in validating systems and GxP-related applications. Perform reviews to ensure regulatory compliance per customer SOPs. Execute end-to-end validation of GxP applications and conduct document/process compliance analysis. Adept with Agile and Waterfall methodologies. Define requirement specifications, functional specifications/User stories/acceptance criteria, and ensure completeness of test scripts with traceability. Ensure risk assessment is completed for all requirements and that test cases are designed in reference to identified risk levels. Onsite Test Lead with management of testing teams across the entire validation testing life cycle, including test planning, test case design, test execution, and defect management activities. Author Validation Plan and compile Validation Summary Report, generate RTM, conduct reviews, and ensure Operational Procedures for the application are prepared. Manage small change implementations related to change requirements. Must Have
Validation Testing Hands-on experience in ALM/Codebeamer, Jira, Life Science Domain
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Job details describe a role requiring extensive experience in validating systems and GxP-related applications, with responsibility for reviewing GxP systems to ensure regulatory compliance per customer SOPs. The position involves end-to-end validation of GxP applications, with document/process compliance analysis and familiarity with Agile and Waterfall methodologies. Responsibilities
12 years of experience in validating systems and GxP-related applications. Perform reviews to ensure regulatory compliance per customer SOPs. Execute end-to-end validation of GxP applications and conduct document/process compliance analysis. Adept with Agile and Waterfall methodologies. Define requirement specifications, functional specifications/User stories/acceptance criteria, and ensure completeness of test scripts with traceability. Ensure risk assessment is completed for all requirements and that test cases are designed in reference to identified risk levels. Onsite Test Lead with management of testing teams across the entire validation testing life cycle, including test planning, test case design, test execution, and defect management activities. Author Validation Plan and compile Validation Summary Report, generate RTM, conduct reviews, and ensure Operational Procedures for the application are prepared. Manage small change implementations related to change requirements. Must Have
Validation Testing Hands-on experience in ALM/Codebeamer, Jira, Life Science Domain
#J-18808-Ljbffr