CSV Compliance Specialist

3 weeks ago


Decatur, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Qualifying/ re-qualifying cloud-based environment IaaS, SaaS, PaaS
  • Review validation deliverables in project initiation phase - User Requirement Specifications (URS) and GxP Assessment, Functional Specifications, Design Specifications, Configuration Specifications, Technical Specifications, etc.
  • Preparing or reviewing validation deliverables in testing phase Protocols and Test Scripts for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Requirement Traceability Matrix (RTM) report, 21 CFR Part 11 Assessment, Summary reports.
  • Computer Systems Validation 7+ years
  • Proficient in Technical Writing, MS Office and Adobe documentation software
  • Author, Execution, & Review of CSV SOP's, Templates, Change Controls, Deviation tasks, CAPA tasks
  • Knowledge of Compliance Guidance's related to CSV.


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