Analyst - Computer Software Validation
Veeva Systemsover 3 years ago
Zagreb, CroatiaEntry Level / Mid Level
Responsibilities
- Participate in RTSM requirement gathering sessions with clients and team members.
- Collaborate with RTSM Development and Project Management teams to define clear and compliant requirements.
- Ensure requirements are tested adequately using a risk-based approach.
- Develop and maintain CSV deliverables including specifications, test scripts, and summary reports.
- Manage validation testing cycles and resolve issues and enhancement requests.
- Maintain change control documentation for ongoing validation of the RTSM system.
- Provide technical expertise in computer system validation and applicable regulations.
- Support customers in RTSM validation activities as needed.
Requirements
- 1+ year of experience in CSV for clinical trial software.
- Working knowledge of the software development cycle (SDLC).
- Familiarity with GCP Guidance such as 21 CFR Part 11 and EU Annex 11.
- Exceptional attention to detail.
- Good interpersonal skills and ability to communicate effectively in English.
Benefits
- Flexible work environment with the option to work from home or in the office.
- Commitment to diversity and inclusion in the workplace.
Tech Stack
About Veeva Systems
Veeva Systems builds cloud software and data products for life sciences, including Veeva CRM and the Veeva Vault suite for clinical, regulatory, and quality operations. It sells subscriptions and services to biopharma and related companies to manage R&D, compliance, and commercial workflows. Founded in 2007 and headquartered in Pleasanton, California, Veeva is publicly traded on the NYSE and has operated as a Public Benefit Corporation since 2021.