Job Description
Are you interested in taking the next step in your career in Computer System Validation in the pharmaceutical industry? Are you ready to challenge yourself in a highly-regulated and fast-paced environment? Are you experienced in IT Validation for GxP and enterprise systems and ready to work fully remote? You could be the perfect candidate for this opportunity! Don't hesitate,
We are seeking a Validation Tester to support a global programme delivering Computer System Validation (CSV), Computer Software Assurance (CSA) and risk management activities across GxP-regulated systems within the Life Sciences sector.
Key Responsibilities
1. Test Design and Execution
- Design, review and execute test cases, test scripts and test protocols for enterprise IT systems.
- Execute Operational Qualification (OQ) testing in accordance with approved test protocols and validation procedures.
- Review requirements and acceptance criteria to ensure test cases adequately cover the intended functionality.
- Record test results accurately and capture appropriate supporting evidence.
- Identify unexpected results, gaps in test coverage and potential issues during test execution.
2. Validation Documentation and Traceability
- Prepare, review and maintain validation lifecycle documentation, including test protocols, test scripts, test execution records, test reports and supporting validation deliverables.
- Maintain traceability between User and Functional Requirements Specifications (UFRS), test cases, execution results and supporting evidence.
- Ensure test documentation is accurate, complete, consistent and compliant with Good Documentation Practices (GDP).
- Identify missing information, documentation inconsistencies and traceability gaps, raising these with the appropriate team members.
3. Defect Management and Issue Resolution
- Identify and document defects encountered during test execution.
- Write clear, factual and reproducible defect descriptions, including expected results, actual results and relevant supporting evidence.
- Maintain accurate defect records using programme tools such as qTest or approved comments logs, where applicable.
- Retest resolved defects and document the results in accordance with approved procedures.
4. Quality and Compliance
- Ensure testing activities are completed in accordance with applicable GxP requirements and approved protocols.
- Check that test evidence supports the recorded results and demonstrates whether acceptance criteria have been met.
Required Experience and Qualifications
- Experience in software testing, IT system validation or Computer System Validation (CSV), within life sciences' environments.
- Practical experience designing and executing test cases, test scripts or test protocols.
- Experience with OQ testing or equivalent formal qualification testing activities.
- Understanding of validation lifecycle documentation, including test protocols, test reports, Validation Plans and RTMs.
- Experience recording test results and maintaining traceability between requirements, test cases and supporting evidence.
- Familiarity with test management or validation tools such as qTest, Confluence, ALM, Kneat or equivalent platforms.
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid holidays
Location:
UK | remote
IT Test Validation Engineer employer: Oxford Global Resources
Join a leading global life sciences organisation in East Grinstead, where you will be part of a dynamic team dedicated to producing high-quality diagnostic and laboratory products. With a strong emphasis on employee development, you will benefit from comprehensive training and career growth opportunities in a supportive work culture that prioritises safety and quality. Enjoy a competitive salary and benefits package while contributing to meaningful advancements in healthcare.
