Offer summary
Qualifications:
Minimum 1 year of experience in Computer Software Validation (CSV) for clinical trial software, Knowledge of software development cycle (SDLC), Familiarity with GCP Guidance like 21 CFR Part 11, EU Annex 11, Excellent attention to detail.
Key responsabilities:
- Participate in RTSM requirement gathering sessions and collaborate with Development and Project Management teams
- Ensure clear, testable, and compliant requirements are defined and adequately tested
- Develop and maintain CSV deliverables, manage testing cycles, resolve issues, and maintain change control documentation
- Provide technical expertise, support customers in RTSM validation activities