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A skilled Senior Test Engineer is required to lead test efforts and ensure high-quality releases while maintaining regulatory compliance. The role involves designing and reviewing test cases, executing test plans, and documenting results.
The successful candidate will be responsible for performing manual and/or automated testing to ensure software products meet regulatory and functional requirements. This includes developing and executing test cases for software applications, validating compliance with industry regulations, and collaborating with cross-functional teams.
Key Responsibilities:
- Develop and execute test cases for software applications
- Validate compliance with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5, HIPAA, ISO 13485)
- Collaborate with developers, services, stakeholders, and regulatory teams to understand requirements and ensure compliance
- Perform defect tracking and reporting using tools like JIRA, HP ALM, or Bugzilla
- Execute SQL queries to validate database integrity
- Conduct API testing using tools like Postman or RestAssured
- Maintain test documentation, including test cases, test scripts, and execution logs
- Design and execute test plans, test cases, and test scripts for complex applications
- Develop and maintain automation frameworks (Selenium, TestNG, Cypress, Playwright, RobotFramework)
- Perform risk-based testing and ensure validation of GxP systems
- Lead test strategy and defect management, working closely with development teams
- Implement CI/CD pipelines for test automation and integration
- Provide guidance and mentorship to test engineers
- Stay updated on emerging trends and best practices in testing and recommend process improvements
Essential Qualifications:
- Demonstrated excellent verbal and written communication skills
- Excellent analysis skills with a tenacious attention to detail
- Excellent conflict resolution skills
- Agile Testing, Testing Lifecycle knowledge & Scrum Methodologies
- Working with any Test Management Tools like HP ALM, Jira , Xray, Zephyr , IBM Rational , TestRail / TestMo
- Advanced skills in Manual & Automation Testing (Selenium, Cucumber, Cypress , RobotFrameoork, Java, PlayWright)
- Performance Testing (JMeter, LoadRunner)
- API Testing & Automation design
- Strong Knowledge of CSV (Computer System Validation)
- DevOps & CI/CD (Jenkins, Docker, GitHub Actions)
- Risk-Based Testing (FMEA, ALCOA+ Data Integrity)
Desired Qualifications:
- 5+ years of working experience with at least one or more year implementing or testing applications in the clinical research/trials domain
- Software development experience
- Automation using Java /Selenium, Python , Cypress, Playwright is a plus , Bdd /Cucumber is a plus
- Robotframework , JMeter knowledge is a plus
- Knowledge of File storage solutions & Cloud concepts is a plus
