Sr CSV Consultant

2 weeks ago

Irvington, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • ct in the Computerized Systems Validation Leadership role on various company projects immediate focus will be on periodic reviews of the current validated state of the computerized systems in production.
  • The reviews may include inspection of the documentation related to the initial system validation, change controls, relevant CAPA activities (tracking and closure of the open system issues), backup and recovery activities, proper implementation of system administration SOPs, etc.
  • Report on the review findings, and work with the management to improve the process based on the findings and observations (e.g., identify and communicate trends, propose resolution that may include procedural documentation updates (SOP, templates, etc.) or training, etc.)
  • The job is expected to involve typical CSV Leadership responsibilities on various projects.
  • s a project CSV Lead, define release validation strategy based on the company procedural framework, author the typical validation and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, URS/FRS, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts, Testing Defects, etc.