Computer Systems Validation Specialist | Pune

The Computer Systems Validation (CSV) Specialist, Trial Interactive reports to TransPerfect’s Director, QA & systems Validation, Trial Interactive and impacts all aspects of TransPerfect’s Life Sciences 21 CFR Part 11 and GCP/ICH compliance, as well as the latest ISO 9001 standard certified quality management systems worldwide. The CSV Specialist, Trial Interactive plays a vital role in ensuring that computerized systems are developed, tested, released, and maintained in a validated state.

• Responsible for the continued compliance and further expansion of the TransPerfect corporate Quality Management Systems (QMS) in the area of Computerized Systems Validation within the Trial Interactive division and consulting to other TransPerfect divisions as needed. This includes, but is not limited to, the following areas:

o Software Development Life Cycle

o Commercial off the shelf (COTS) Validation and subsequent 3rd Party Vendor Qualification

o Infrastructure Qualification

o Regulatory Compliance Evaluations

o Validation Package Reviews/Approvals

o Operational Readiness

o Periodic Reviews

o Change Control

o Client-specific Validation Services

• Investigate validation specific complaints or adverse experiences and operational problems to identify root cause and effective corrective and preventive actions; provide the formal Client Escalation Report back to the client

• Actively maintain and improve colleagues’ awareness of Systems Validation processes, policies, and procedures through training and any other methods

• Travel up to 20% domestically and internationally as required

• Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor