Work with Business Analysts, Software Developers and End Users to ensure that system functionality is understood and works according to specifications,
Develop Test scripts,
Execute test scripts and feedback results,
Validate Software,
Develop, implement, and maintain test procedures and tools for system testing, documentation, and environments,
Log software development defects into tracking database,
Contribute to the test strategies and projects in order to streamline and shorten the overall testing cycle,
Perform computer systems validation activities to ensure that IT systems meet regulatory requirements (FDA),
requirements-expected :
Formal training in Software QA,
Minimum of 2 years relevant Software Quality Assurance experience preferably in pharmaceutical or medical devices industry,
All systems test activities including planning, test script development and test execution,
Proven experience in computer system validation of numerous applications on a variety of platforms,
Willing and able to travel,
Bachelor’s Degree in Computer Science or Engineering,
Presentation and problem solving skills.
Formal qualifications/certification in Software Quality Assurance (ISEB/ISTQB),
Knowledge of FDA/ISO standards and regulatory requirements,
Knowledge of GAMP5, QSR 820.70i, 21CFRPart11,
JD Edwards Enterprise One ERP,
Test Automation Tools,
Relational Databases,
Programming and Scripting,
Web technologies,
Client Server computing,
Microsoft .NET, Java J2EE, HTML.
offered :
Stable job in professional team,
Interesting career path in an international organization,
