We are looking for a Validation Lead candidate to join our client who is a leader in software supporting clinical trials. Normally this is office based in Cambridge, but currently home working.

The role is a key function in their 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 testing as the test and validation tools.

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

The role will be responsible for:

• Implementing a formal justifiable risk-based approach to the scope of functional requirements (IQ/OQ) testing
• When required by the Client, implement a formal justifiable risk-based approach to the scope of User Acceptance Testing (UAT)
• Implement industry best practice for CSV including the scope of vendor and client responsibilities
• Establish objectives to optimise product and client configuration quality
• Review test acceptance criteria against requirements
• Review test execution outputs from Selenium as well as Azure Test Manager runs for manual UAT
• Create, collate and archive SDLC documentation using templates to generate an approved, auditable validation package.
• Ensure that all clients' validation documents meet regulatory requirements by appropriate documentation as evidence of testing against requirements.
• Process improvement

This is a great opportunity for someone who is interested in making more use of automated testing in a heavily regulated environment.

Our client is passionate about our culture and values and we are looking for someone who will thrive in a hardworking, energetic, creative and team-oriented environment.