Senior Computer Systems Validation Associate | Pune

The Senior Computer Systems Validation (CSV) Associate, Trial Interactive, is responsible for supporting TransPerfect's Life Sciences 21 CFR Part 11 and GCP/ICH compliance and helping to maintain the certified ISO 9001 Quality Management systems across all computerized systems. This role ensures that TransPerfect’s computerized systems are developed, validated, and maintained in a state of compliance with regulatory requirements. Reporting to the QA Manager, the Senior CSV Associate, Trial Interactive takes on an active role in supporting CSV activities, mentoring junior associates, and engaging with cross-functional teams to meet project goals.

• Responsible for executing the TransPerfect corporate Quality Management Systems (QMS) in the area of Computerized Systems Validation within the Trial Interactive division. This includes, but is not limited to, the following areas:

o Software Development Life Cycle

o Commercial off-the-shelf (COTS) validation and subsequent third-party Supplier Qualification

o Infrastructure qualification

o Regulatory compliance evaluations

o Validation package reviews

o Operational readiness

o Periodic reviews

o Change control

• Investigate validation-specific complaints or adverse experiences and operational problems to identify root causes and effective corrective and preventive actions

• Support the QA team in writing 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

• Help mentor and train junior team members

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