Overview
On Site
Accepts corp to corp applications
Skills
GxP
Regulatory Compliance
Agile
Waterfall
User Stories
Test Scripts
Risk Assessment
QA Management
Management
Test Plans
Test Cases
Test Execution
Defect Management
Reporting
RTM
Testing
Application Lifecycle Management
JIRA
Life Sciences
Job Details
Role - Validation Test Lead
Location - King of Prussia, PA (Hybrid)
Location - King of Prussia, PA (Hybrid)
Job Details:
12 years' Experience in Validating systems and Experienced in GxP related applications. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs. Expertise on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology.
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.
As a onsite Test Lead managing of testing teams on entire validation testing life cycle on test planning, Test cases design, test execution and defect management activities
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.
Must Have:
Validation Testing
Hands on in ALM/Codebeamer, Jira, Life Science Domain.
Validation Testing
Hands on in ALM/Codebeamer, Jira, Life Science Domain.
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