The Opportunity
The Test Consultant will work within the testing team, focusing on Computer System Validation (CSV) efforts. This role is hands-on and will involve creating and executing test cases, ensuring that all systems comply with regulatory requirements.
The role will include but not be limited to :
- Participate in the creation and execution of test scripts and protocols for CSV projects.
- Ensure all testing activities comply with GxP, FDA regulations, and 21 CFR Part 11.
- Support the development of validation documentation including test scripts, traceability matrices, and test reports.
- Collaborate with the Test Lead to address defects and validate system functionality.
- Assist in maintaining accurate and complete documentation for audit and regulatory review.
- Keep up-to-date with regulatory changes and best practices in CSV.
Your Experience
Bachelor's degree in IT, Engineering, or a related field.3+ years of experience in software testing, with exposure to CSV.Strong experience in SAP technology.Understanding of regulatory requirements (e.g., GxP, FDA 21 CFR Part 11).Experience in writing and executing test scripts, and documenting validation efforts.Strong attention to detail and organizational skills.Good communication and teamwork abilities.Experience in Life Sciences, or process manufacturing industries, particularly in sectors such as pharmaceutical, medical devices, medical manufacturing and chemicals, would be advantageous.