Must have

• Quality assurance

• ISTQB

• ISO

• FDA

• HTML

• J2EE

• Java

• .NET

• GAMP5

• Microsoft

• English

Nice to have

• ERP

• Relational database

• Communication skills

Requirements description

• 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.

Offer description

Location: Remote

Employment type: Full-time, employment contract

Your responsibilities

1. Collaborate with Business Analysts, Software Developers, and End Users to understand system functionality and verify that solutions meet specifications.
2. Develop detailed test scripts and test cases.
3. Perform software validation activities and ensure compliance with regulatory standards (e.g., FDA).
4. Develop, implement, and maintain test procedures, testing tools, and test environments.
5. Log and track software defects using the client’s defect-tracking systems.
6. Contribute to test strategy planning to improve efficiency and shorten testing cycles.

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