Our client is growing at pace due to the success of their Industry leading products for clinical trials. Are you an experienced software tester with Life Science experience looking for a lead role?

The Software Test Lead role is a key function in our SDLC and client project delivery models. Our SDLC follows an Agile approach, using a Kanban model in MS Azure DevOps leveraging Test Manager, Modern Requirements and Selenium as the test and validation tools.

The Software Lead role will be involved with both product releases and client/study implementations.

The role will be responsible for the following:

• Support the System Owner and Validation Lead with the System Risk Assessment and development of the Validation Plan
• Develop the test strategy, including an overview of what areas of the system will be covered by automated tests and manual tests
• Develop the test plan based on the system requirements and test acceptance criteria
• Prepare test estimates and resource plan for delivery
• Creation and maintenance of test work items in product development tracking tools
• Manage test resources
• Tracking planned versus actual work, and remaining work
• Report test progress to Product Manager
• Ensure quality of the test deliverables
• Review test cases to ensure they meet quality standards, and cover the acceptance criteria with required evidence
• Report test pass/fail metrics, for manual and automated test pipelines
• Work with testers to investigate and resolve test failures
• May also be required to write/develop test cases

During product validation phase works closely with the Validation Lead to:

• Support validation readiness assessment
• Oversee test execution
• Report pass/fail metrics
• Support Validation Lead with test incident investigation and resolution
• Provide input into validation/test reports

This role will also provide input into process improvement for software testing

The Candidate

Experience in software within GxP or other regulated environment that have used both manual and automated testing tools and processes would. Industry experience with GCP would be advantageous, but not essential.

Interpersonal Skills

• Self-motivated
• Strong communication, ability to make a positive impact with internal and external stakeholders
• Enjoy working in a small, results-oriented team
• Willingness to provide input to project plans and approach
• Excellent attention to detail
• Enjoy working on a variety of projects
• Ability to take responsibility for the consistency and quality of validation deliverables
• Interest in optimizing test processes
• Experience in test automation technology and processes
• Desire to develop new skills

Technical Skills (not exclusive)

The candidate must have good knowledge of the following:

• Computer system development life cycle (SDLC) and the required testing in each phase
• Specification and test approval roles and responsibilities for the SDLC deliverables and validation requirements

• Experience of developing test/validation artifacts such as test strategy, test plan, requirement trace matrix
• Experience of test execution cycles and metrics
• Experience of working within agile/kanban software development life cycle
• Experience of using Microsoft Azure DevOps for test planning and test case writing is an advantage but not essential
• Working knowledge of industry standards for software development and validation would be an advantage but not essential i.e. ISO/IEC 9003: 2004, Software Engineers - Guidelines for the application of ISO 9001:2000 to computer software; ICH E6, GaMP5, FDA Regulation 21 CFR Part 11, FDA Guidance for Industry on Computer Systems used in Clinical Investigations, FDA General Principles for Software Validation, EudraLex Volume 4 Annex 11: Computerized Systems.

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