About the job
The Computer Systems Validation (CSV) Specialist at TransPerfect's Trial Interactive division plays a crucial role in ensuring compliance with 21 CFR Part 11 and GCP/ICH regulations, as well as upholding ISO 9001 certified quality management systems globally. This position is integral to the development, testing, release, and maintenance of validated computerized systems.
KEY RESPONSIBILITIES
Ensure ongoing compliance and enhancement of TransPerfect's Quality Management Systems (QMS) related to Computerized Systems Validation, primarily within the Trial Interactive division, while also providing consulting to other divisions as required.
Oversee various aspects including:
- Software Development Life Cycle
- Validation of Commercial Off-the-Shelf (COTS) software and Third-Party Vendor Qualification
- Infrastructure Qualification
- Regulatory Compliance Evaluations
- Validation Package Reviews and Approvals
- Operational Readiness Assessments
- Periodic Reviews
- Change Control Management
- Client-specific Validation Services
Investigate validation-related complaints and operational issues, identifying root causes and implementing effective corrective and preventive actions, including formal reporting to clients.
Enhance team awareness of Systems Validation processes through training and other methods.
Willingness to travel up to 20% domestically and internationally as needed.
Perform additional tasks as assigned by management.

