Validation Specialist API

Sun Pharma
Any Location, IN
Job Description
The Validation Specialist API will manage the Plant GxP Application Inventory and support CSV projects as the Technical Owner for Computer System Validation (CSV) documentation related to GxP applications. They will conduct periodic CSV and QMS activities throughout the system lifecycle, from implementation to retirement.

Requirements

  • Manage the Inventory of GxP Applications for Manufacturing & Quality IT
  • Support the Planning and review of validation deliverables for CSV Projects
  • Support in Preparation, reviews and Approval of Computer System Validation (CSV) documents as per implemented processes as Technical Owner
  • Ensure compliance of GSOP's/SOP's related to Computer System Validation documentation and regulatory requirements during execution of CSV Project
  • Identify the continuous improvement opportunities for CSV projects
  • Documentation and control for management of IT CSV Documents
  • Timely completion of validation activities with zero timeline extensions
  • Full audit readiness with complete and compliant documentation
  • Effective and timely closure of all related QMS records (deviations, CAPA, change controls, etc.)

Benefits

  • Robust benefits
  • Opportunities to foster personal and professional growth
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