Analyst, Computer Software Validation
Veeva Systems
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇭🇷 Croatia
Visit company websiteJob Level
Junior
Tech Stack
Google Cloud PlatformSDLC
About the role
- Participate in RTSM requirement gathering sessions with clients and RTSM team members
- Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
- Ensure requirements are adequately tested following a risk-based approach
- Develop and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices
- Manage Validation testing cycles and resolution of issues and enhancement requests
- Maintain change control documentation to ensure ongoing validation of the RTSM system
- Provide technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
- Support customers as needed in RTSM validation activities
Requirements
- 1+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
- Working knowledge of software development cycle (SDLC)
- Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
- Exceptional attention to detail
- Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and skill levels
Benefits
- Work Anywhere policy, allowing flexibility to work from home or in office
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
computer system validationrequirements specificationstest scriptssummary reportstrace matricesvalidation testingchange control documentationrisk-based approachsoftware development cycleGCP Guidance
Soft skills
attention to detailinterpersonal skillscommunication skills