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Full-time CSV Lead

at golokglobal in United States Of America

Role: CSV Lead
- Work with the development and business to plan the testing approach and then execute on the test plans.
- Working in an agile development environment, contribute to sprint planning efforts by evaluating complexity and estimation of the test tasks.
- Plan, create and maintain test environments for various use cases.
- Review specification and create/edit test cases or suites accordingly.
-Validate applications against specification using documented test procedures; report the defects using different tools like JIRA or ALM.
- Update testing documents in CDOCS.
- Collect and report metrics for test runs.
- Collaborate with other team members, software developers and management to ensure comprehensive test coverage.
- Ability to understand technical specifications and determining the test scenarios accordingly and putting them in test scripts.
- Perform regression, integration and release testing in different environments.
- Design, develop, maintain and troubleshoot automated suits of tests.
- Execution of different test cases in ALM and route them for approvals.
Experience Requirements:
Experience in software engineering in the Life Science Industry.
- Experience of working as CSV Lead for GAMP 5 systems, absolutely mandatory.
- Experience in Manual/Automation testing.
- Expertise in use and validation of GxP systems/regulated environment.
- Knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
- Knowledge of Amgen QA System - ALM, ServiceNow.
- Proven success in leading all delivery stakeholders in implementation and adoption of testing framework.
- Working knowledge of Project Management and testing tools (JIRA, ALM, etc.)
- Understand of QA process for software development, debugging and release
- Critical thinker and problem solving skills.
- SAFe for Teams Certified.
Reference : CSV Lead jobs


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Published at 29-09-2022
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