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Senior Computer Systems Validation Associate at TransPerfect | Pune

TransPerfectPune, Mahārāshtra, India
On-site Full-time

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Experience Level

Experience

Qualifications

REQUIRED SKILLSIn-depth knowledge of e-Clinical technologies. Commitment to TransPerfect’s quality standards. Exceptional problem-solving and critical thinking abilities, with a capacity for rapid learning. Strong organizational skills and the ability to manage multiple tasks to meet deadlines. Excellent written and verbal communication skills in English. Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).

About the job

As a Senior Computer Systems Validation (CSV) Associate within the Trial Interactive division at TransPerfect, you will play a crucial role in ensuring compliance with Life Sciences 21 CFR Part 11 and GCP/ICH regulations. You will assist in upholding the certified ISO 9001 Quality Management systems across all computerized systems. This position requires you to ensure that TransPerfect’s computerized systems are developed, validated, and maintained in accordance with regulatory standards. Reporting directly to the QA Manager, you will actively support CSV initiatives, mentor junior associates, and collaborate with cross-functional teams to achieve project objectives.

KEY RESPONSIBILITIES

  • Execute TransPerfect's corporate Quality Management Systems (QMS) pertaining to Computerized Systems Validation in the Trial Interactive division, including:

• Software Development Life Cycle

• Validation of Commercial off-the-shelf (COTS) products and third-party Supplier Qualification

• Infrastructure qualification

• Evaluations for regulatory compliance

• Review of validation packages

• Operational readiness assessments

• Conduct periodic reviews

• Manage change control procedures

  • Investigate validation-related complaints or operational issues to identify root causes and implement effective corrective and preventive measures.

  • Assist the QA team in crafting formal Client Escalation Reports.

  • Enhance colleagues’ understanding of Systems Validation processes, policies, and procedures through training and other engagement methods.

  • Mentor and train junior team members.

  • Complete additional tasks as assigned by the manager/supervisor.

About TransPerfect

TransPerfect is a leading provider of global language and technology solutions, committed to delivering the highest quality services in the Life Sciences sector. With a strong focus on compliance and quality management, TransPerfect is dedicated to helping clients navigate regulatory requirements and achieve their objectives efficiently.

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