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.