IT Quality Assurance Engineer

6 dni temu

Łódź, Łódź Voivodeship, Polska Antalpl Pełny etat 40 000 zł - 80 000 zł rocznie
IT Quality Assurance Engineer with the pharmaceutical, medical device, biotech or life-science industry experience 
 
Location: Remote/Hybrid (Poland)

Employment type: Full-time, employment contract
 
Key Responsibilities
 
  • Collaborate with Business Analysts, Software Developers, and End Users to understand system functionality and verify that solutions meet specifications.
  • Develop detailed test scripts and test cases.
  • Perform software validation activities and ensure compliance with regulatory standards (e.g., FDA).
  • Develop, implement, and maintain test procedures, testing tools, and test environments.
  • Log and track software defects using the client's defect-tracking systems.
  • Contribute to test strategy planning to improve efficiency and shorten testing cycles.
  • Perform computer systems validation (CSV) across multiple platforms and technologies.
  • Provide ongoing software quality assurance support to the client's IT Department.
Required Skills & Qualifications
 
  • MUST HAVE - Experience in the pharmaceutical, medical device, biotech, or life-science industry/projects.
  • Minimum 2 years of commercial experience.
  • Formal qualifications or certifications in Software Quality Assurance (ISEB / ISTQB).
  • Strong knowledge of FDA/ISO standards and regulatory requirements.
  • Understanding of GAMP5, QSR 820.70i, 21 CFR Part 11.
  • Familiarity with test automation tools and frameworks.
  • Knowledge of programming and scripting.
  • Working knowledge of Microsoft .NET, Java J2EE, HTML.
  • Fluent English.

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