GXP Validation Tester
7 days ago
We are seeking an experienced GxP validation tester with a strong background in software validation and regulatory compliance. The ideal candidate will have hands-on experience in GxP validation processes, excellent domain knowledge, and a working understanding of automation testing.
Key Responsibilities:- Perform GxP software validation activities, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11.
- Develop and execute validation deliverables, including Validation Plans, Test Plans, Test Cases, and Validation Summary Reports.
- Collaborate with cross-functional teams to ensure adherence to GxP guidelines throughout the software development lifecycle.
- Conduct functional, regression, and risk-based testing to validate system integrity.
- Document and manage validation evidence, ensuring traceability and audit readiness.
- Support and perform automation testing activities as required (desirable).
- Provide insights and recommendations for process improvement and quality assurance.
- Experience: Minimum 6+ years of overall experience, with at least 3 years in GxP validation.
- Strong understanding of GxP principles, regulatory requirements, and validation lifecycle processes.
- Experience in creating and managing validation artifacts (e.g., URS, FRS, IQ, OQ, PQ, and traceability matrices).
- Good domain knowledge in regulated industries such as pharma, biotech, or life sciences.
- Hands-on experience with testing tools and techniques; automation testing experience is a plus.
- Familiarity with tools like JIRA, HP ALM, or other test management tools is advantageous.
- Strong analytical and communication skills to liaise effectively with stakeholders.
The estimated salary range for this position is $120,000-$150,000 per year, depending on location and experience.
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