Validation Test Lead

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.

• 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.

• Validation Testing
• Hands-on experience in ALM/Codebeamer, Jira, Life Science Domain