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Net2Source (N2S) • Louisville, Kentucky, United States
Salary: 21 CFR Pa
Role & seniority: CSV Testing role (likely individual contributor; contractor/perm unspecified)
Stack/tools: Manual Testing; Data Validation; Computer System Validation (CSV); Test Plan/Test Case creation; Functional/Regression Testing; OQ/PQ testing; 21 CFR Part 11/GxP/GAMP knowledge; SQL (basic); Jira; Confluence; Agile/Scrum
Coordinate with CSV Expert to understand requirements and regulated environment; assist with validation plans, test protocols, and SOPs
Design and execute tests (OQ/PQ as needed); perform system testing against specifications; manage defects and traceability matrices
Maintain knowledge base (Confluence), track tasks in Jira, support risk assessment and risk-based approaches for GxP computerized systems
Manual testing and data validation/verification for healthcare systems
Test plan and test case creation; functional and regression testing
Computer System Validation (CSV); basic SQL knowledge; familiarity with 21 CFR Part 11, GxP concepts; Jira/Confluence; Agile/Scrum
Experience with regulatory validation environments, GDP guidelines, OQ/PQ development, and risk-based testing approaches
Prior CSV validation projects in healthcare/pharma
Location & work type: Remote work; (employment type not specified)
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.
Role - CSV Testing Location - Remote
Key Skill /Skill Specialization: Manual Testing
Mandatory Skills: Manual Testing Data Validation and Verification of Healthcare systems Test Plan Creation Test Case Creation Functional / Regression Testing Comuputer System Validation CSV Desired Skills Job Description
Co-ordinate with CSV Expert to understand the CSV requirements and regulated environment setup
Assist the CSV Expert with validation plans specifications test protocols and standard operating procedures and implementation
Test designing - Operational Qualification OQ Performance qualification PQ - If needed based on FRS URS and by following the GDP guidelines
Carry out system testing against specifications record test result in line with current validation regulation eg 21 CFR Part 11
Defect management
Traceability Matrix creation and maintenance
Should have basic SQL knowledge
Confluence page management create and update knowledge base
Work assignments Co-ordination track sprint goals backlog assist in test execution
Jira task tracking
Good knowledge of defect lifecycle
Good knowledge of GxP Non - GxP concepts 21 CFR Part 11 and GAMP guidelines
Have experience in performing risk assessment and risk-based approach for GxP Computerized system
Excellent communication skills
Knowledge of Agile methodology and Scrum framework
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Regards Damini Account Manger
Office: (201) 479-3769