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Validation Test Lead
Job in
King of Prussia, Montgomery County, Pennsylvania, 19406, USA
Listed on 2025-12-26
Listing for:
TechDigital Group
Full Time
position Listed on 2025-12-26
Job specializations:
-
IT/Tech
IT QA Tester / Automation, Data Analyst -
Quality Assurance - QA/QC
IT QA Tester / Automation, Data Analyst
Job Description & How to Apply Below
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.
- Validation Testing
- Hands-on experience in ALM/Codebeamer, Jira, Life Science Domain
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