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Computer Systems Validation Specialist | Pune

TransPerfectPune, Mahārāshtra, India
On-site Full-time

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Experience Level

Experience

Qualifications

REQUIRED SKILLSProven experience with clinical development study documentation. Strong understanding of eClinical technologies. Commitment to maintaining high-quality standards in alignment with client and company expectations. Excellent problem-solving and critical thinking abilities, with a capacity for rapid learning. Exceptional organizational skills and capability to manage multiple tasks to meet deadlines. Outstanding verbal and written communication skills in English. Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint). EXPERIENCE AND EDUCATIONBachelor’s Degree or equivalent. A minimum of 2 years of experience in the Life Sciences sector. At least 3 years of experience in Computerized System Validation.

About the job

The Computer Systems Validation (CSV) Specialist at TransPerfect's Trial Interactive division plays a crucial role in ensuring compliance with 21 CFR Part 11 and GCP/ICH regulations, as well as upholding ISO 9001 certified quality management systems globally. This position is integral to the development, testing, release, and maintenance of validated computerized systems.

KEY RESPONSIBILITIES

  • Ensure ongoing compliance and enhancement of TransPerfect's Quality Management Systems (QMS) related to Computerized Systems Validation, primarily within the Trial Interactive division, while also providing consulting to other divisions as required.

  • Oversee various aspects including:

    • Software Development Life Cycle
    • Validation of Commercial Off-the-Shelf (COTS) software and Third-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, including formal reporting to clients.

  • Enhance team awareness of Systems Validation processes through training and other methods.

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

  • Perform additional tasks as assigned by management.

About TransPerfect

TransPerfect is a leading provider of global localization services, committed to facilitating communication and understanding across languages and cultures. With a strong focus on quality management systems, the company is dedicated to maintaining compliance with industry regulations in life sciences and beyond.

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