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Software Validation Engineer, QA
QureightSoftware Validation Engineer responsible for delivering high-quality software for clinical trials. Collaborating with multidisciplinary teams to validate and test software solutions for biopharma clients.
Core Competencies
Role fitCore Competencies
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Demonstrates expertise in software testing methodologies, including automated unit, integration, regression, and E2E testing, while ensuring compliance with regulatory standards such as Good Clinical Practice and GAMP 5. Proficient in validating Python-based software stacks and utilizing common testing frameworks and CI/CD tools to enhance product quality.
Highest-signal resume keywords
Software TestingPython-Based Software ValidationAutomated Testing FrameworksCI/CD ToolsComputer Systems Validation
ATS Keywords
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Hard Skills
Automated TestingUnit TestingIntegration TestingRegression TestingE2E TestingPythonPytestPlaywrightSeleniumGitlab
Soft Skills
Problem-SolvingAnalytical MindsetStrong Communication
Certifications & Qualifications
ISO 13485
Industry Keywords
Good Clinical PracticeGAMP 5Computer Systems ValidationRegulatory ComplianceQuality Management System
Tech Stack
Tools & technologiesCloudPythonSelenium
About the role
Key responsibilities & impact- Help implement testing strategies across Qureight’s integrated software stack, including automated unit, integration, regression and E2E tests.
- Ensure that all functional, performance, regulatory, privacy and security requirements are tested to an acceptable level prior to product release.
- Manage test runs; identifying, reporting and tracking any software defects that arise.
- Participate in software design reviews, helping to ensure that all software requirements are clear, concise and testable.
- Contribute to the ongoing improvement of automated processes that produce traceable artefacts.
- Attend sprint planning and stand-up meetings to stay apprised of new feature development work
- Contribute to risk-based computer systems validation (CSV) across a range of commercial and in-house software platforms to ensure compliance with clinical trial, quality and regulatory standards, particularly Good Clinical Practice and GAMP 5.
- Be proactive in suggesting improvements that improve product quality and our way of working.
- Remain up to date with the latest best practices and testing methodologies and frameworks.
Requirements
What you’ll need- Industry experience in software testing (preferably for a cloud-hosted product suite), through previous roles, internships or projects.
- You have experience validating python-based software stacks; familiarity with systems that include machine learning components is advantageous.
- You are skilled in the use of common test frameworks and tools such as pytest, Playwright, Selenium, etc and experienced in the use of CI/CD tools (we use Gitlab).
- You have excellent problem-solving skills, an analytical mindset and strong communication skills.
- It’s a bonus if you have (but not essential):
- You have experience or knowledge (through training or education) of software validation in a regulated industry. (Our software platform is developed under a ISO 13485 certified quality management system, and GxP-validated following GAMP 5 methodology).
- Knowledge formal Computer Systems Validation/Assurance methodologies, e.g, GAMP 5.
- A degree or degree-equivalent in a relevant scientific or technical area, e.g. computer science or engineering, is beneficial, but not essential.
Benefits
Comp & perks- A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, and a contributory pension scheme
- 25 days annual leave, plus bank holidays and enhanced maternity leave
- A diverse work environment that brings together experts in many fields, including software engineering, devops, data science, machine learning, quality assurance, regulatory affairs, and clinical operations.