Computer System Validation Analyst
Key Responsibilities
The CSV Analyst is the hands-on executor of the validation lifecycle. This role focuses on the control, development and execution of test scripts (IQ/OQ/PQ) and the management of validation documentation. It is an essential role for ensuring that software functions exactly as intended before it is released to the business.
Validation Script Development
Write detailed validation documentation and scripts based on Functional Specifications.
Execution & Debugging
Execute dry runs and formal validation protocols. accurately documenting, following operation procedures (OP) and working instructions (WI).
Defect Management
Log and track protocol deviations (defects), work with developers to resolve configuration errors.
Evidence Capture
Capture evidence and log files as objective for validation testing, ensuring they are legible and annotated correctly.
Traceability
Maintain the Requirements Traceability Matrix (RTM) to ensure appropriate coverage of requirements during validation process.
Qualifications
Education
B.S. in a technical field or equivalent experience in IT/Quality.
Experience
5+ years in software validation, QA in a regulated environment.
Technical Mastery
1. Proficiency with test management systems/tools (TestRail, Zephyr, Xray, QMetry, HP Quality Center).
2. Strong understanding of Good Documentation Practices (GDP).
3. Experience with 21 CFR Part 11.
4. Good networks knowledge (protocols, ports, traffic monitoring).
Soft Skills
Meticulous attention to detail (spotting typos in code or specs) and patience with repetitive testing cycles.
Join Our Dynamic Team Today
We’re looking for passionate individuals ready to make an impact in software compliance and quality assurance.