17 hours ago
Hyderābād, IndiaSenior
Responsibilities
- Perform end-to-end validation testing for GxP applications in compliance with regulatory requirements.
- Develop, review, and execute validation plans, test strategies and plans, IQ/OQ/PQ protocols, test scripts, traceability matrices, and validation summary reports.
- Conduct functional, integration, regression, and user acceptance testing for validated systems.
- Execute manual validation test cases and document results with objective evidence.
- Identify, document, track, retest, and close defects.
- Support change control, impact assessments, risk assessments, periodic reviews, audits, and regulatory inspections.
- Review requirements and technical documentation to identify test scenarios.
- Collaborate with business users, QA, development teams, and validation stakeholders while maintaining documentation according to SOPs and quality processes.
Requirements
- At least 5 years of experience as a Validation or Test Engineer.
- Hands-on experience working in a GxP-regulated environment.
- Strong knowledge of Computer System Validation, GAMP 5, FDA 21 CFR Part 11, ALCOA+, and data integrity requirements.
- Experience preparing and executing IQ, OQ, and PQ validation documentation.
- Strong understanding of SDLC and validation lifecycle processes.
- Experience with test management and defect tracking tools such as ALM/QC, Jira, or Azure DevOps.
- Bachelor’s degree in computer science, engineering, life sciences, or a related discipline.
- Preferred qualifications include pharmaceutical, biotech, clinical, laboratory, or life sciences experience; automated testing exposure; cloud-based validated systems experience; and database or SQL knowledge.
- Strong analytical, problem-solving, communication, documentation, and independent-working skills.