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Role: Test Manager (GAMP5 Compliant Software)

Location: Oxford-based (on-site or hybrid)

Contract Duration: 6 months (potential to extend)

Key Responsibilities

• Define and implement test strategies aligned with GAMP5 and risk-based testing
• Plan and oversee testing across all phases: unit, integration, system, UAT, performance, and security
• Ensure validation activities comply with FDA 21 CFR Part 11, EU Annex 11, and GxP standards
• Create and maintain all validation documents: test plans, protocols (IQ, OQ, PQ), traceability, reports
• Lead test execution and defect management using tools like Jira/Xray
• Produce test summaries, quality metrics, and dashboards for internal stakeholders
• Continuously improve testing processes, tools, and regulatory practices
• Support software validation audits (internal and external)

Required Skills & Experience

• Degree in Computer Science, Software Engineering, or related technical field
• 3+ years in QA/testing in regulated industries (pharma, biotech, med device)
• Strong working knowledge of GAMP5 and validation requirements
• Broad experience in manual and functional testing, regression, UAT, and non-functional testing
• Proficient in test management and documentation tools (Jira, Xray, Confluence, MS Office)
• Excellent communicator with strong problem-solving and attention to detail
• Able to work independently within agile, collaborative teams
• ISTQB or equivalent certification
• Experience with automated testing frameworks
• Knowledge of Agile/Scrum, AWS/cloud, embedded systems, and IoT devices
• Familiarity with eQMS platforms (e.g., Ketryx, Cognidox)

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Consulting

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