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Computer System Validation and Regulatory Compliance Specialist at TransPerfect

Department: IT

Setup
On-site
Location
Pune, Maharashtra
Level
senior
Posted

Description

The Computer System Validation and Regulatory Compliance Specialist will lead and support validation of technology platforms, applications, and services across GxP-regulated systems. Responsibilities include developing validation documentation, collaborating with cross-functional teams, supporting audits, performing revalidations, providing compliance training, and embedding data integrity principles. The role requires at least 10 years of CSV experience in regulated industries, expertise in GxP, GAMP 5, 21 CFR Part 11, and data integrity, plus experience validating systems such as LIMS, ERP, eQMS, cloud platforms, and SaaS.

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