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CSV (Computer Systems Validation) Manager

Transperfect·Pune

Pay not stated7–9 yrsFull-time
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About the role

The CSV (Computer Systems Validation) Manager, Trial Interactive leads and advances TransPerfect's global Life Sciences compliance initiatives, including 21 CFR Part 11, GCP/ICH requirements, and the company's ISO 9001-certified Quality Management System (QMS).

What you'll do

  • Serving as the primary subject matter expert (SME) and point of escalation during client audits, regulatory inspections, and internal quality reviews

What you need

  • 7–9 years in legal & compliance
  • Compliance
  • Documentation
  • Technical writing
  • ISO 9001
  • GCP
  • Vulnerability assessment
  • B.Tech or B.E. or B.Sc or BCA

Good to have

  • SOP writing

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