Responsibilities
- Develop, carry out, and oversee software validation tasks following internal policies and regulatory standards such as GxP, FDA, and ISO.
- Create and manage validation records, including validation plans, risk analyses, test scripts, test summaries, and traceability documentation.
- Evaluate system requirements, design documents, and user stories to confirm testability and proper control measures.
- Perform or review functional, integration, regression, and user acceptance tests.
- Support change management by evaluating validation implications and revising documentation accordingly.
- Work with Engineering and Product teams to detect risks early and integrate quality into development workflows.
- Assist in audits and regulatory inspections by organizing documentation and helping formulate responses.
- Enhance validation processes, templates, and tools to improve efficiency and support growth.
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