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Computer Systems Validation Specialist at TransPerfect | Pune

TransPerfectPune, Mahārāshtra, India
On-site Full-time

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Experience Level

Experience

Qualifications

REQUIRED SKILLSExperience in clinical development study documentation. Familiarity with eClinical technologies. Commitment to meeting both client and corporate quality standards. Strong problem-solving and critical thinking abilities, with a quick learning aptitude. Excellent organizational and multitasking skills to meet deadlines. Outstanding written and verbal communication skills in English. Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint). EXPERIENCE AND EDUCATION REQUIREMENTSMinimum Bachelor’s Degree or equivalent. At least 2 years of experience in the Life Sciences industry. A minimum of 3 years of experience in Computerized System Validation.

About the job

As a Computer Systems Validation (CSV) Specialist within the Trial Interactive division at TransPerfect, you will report directly to the Director of QA & Systems Validation. Your role is crucial in ensuring compliance with 21 CFR Part 11 and GCP/ICH standards in the Life Sciences sector, alongside upholding the latest ISO 9001 quality management systems globally. You will be instrumental in the development, testing, release, and maintenance of validated computerized systems.

KEY RESPONSIBILITIES

  • Oversee compliance and enhancement of TransPerfect’s Quality Management Systems (QMS) within Computerized Systems Validation for Trial Interactive, providing consulting support to other divisions as needed. Areas of focus include:

    • Software Development Life Cycle
    • Validation of Commercial Off-the-Shelf (COTS) products and 3rd 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, culminating in a formal Client Escalation Report.

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

  • Willingness to travel up to 20% both domestically and internationally as required.

  • Perform any additional tasks assigned by your manager or supervisor.

About TransPerfect

TransPerfect is a leading provider of language and technology services, committed to delivering high-quality solutions to clients in various industries, including Life Sciences. With a focus on compliance and quality management, we strive to maintain the highest standards across our global operations.

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