About the job
The Senior Computer Systems Validation (CSV) Associate at TransPerfect is pivotal in ensuring compliance with 21 CFR Part 11 and GCP/ICH regulations within our Life Sciences division. This role is instrumental in upholding the integrity of our ISO 9001 certified Quality Management Systems across all computerized systems. As a key member of our QA team, you will report directly to the QA Manager, taking an active role in CSV activities, mentoring junior associates, and collaborating with cross-functional teams to achieve project objectives.
KEY RESPONSIBILITIES
Execute the corporate Quality Management Systems (QMS) specifically focused on Computerized Systems Validation within the Trial Interactive division, covering:
• Software Development Life Cycle
• Validation of Commercial off-the-shelf (COTS) products and third-party Supplier Qualification
• Infrastructure qualification
• Regulatory compliance assessments
• Validation package assessments
• Operational readiness checks
• Periodic system reviews
• Change control processes
Investigate validation-specific issues and operational challenges to determine root causes and implement corrective actions.
Assist the QA team in drafting formal Client Escalation Reports.
Enhance knowledge of Systems Validation processes among colleagues through training and other engagement methods.
Mentor and train junior team members.
Complete other tasks as assigned by your supervisor.

