QA Auditor

Job Description

Provide global regulatory oversight of validation management as part of the Quality Management System. This oversight includes developing IQVIA Laboratories policy and procedure related to GxP compliance, guidance, audit support, review of validation deliverables, and approving release for use as related to Laboratory System Validations.

RESPONSIBILITIES
Essential Functions
• Plan, schedule, conduct, report, and close Clinical Trial Laboratory Technology Systems Audit activities in IQVIA globally, or its affiliates, to assess compliance with applicable GXP regulations/ GAMP (Good Automated Manufacturing Practices) guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions. Thorough auditing evaluates the proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in general.
• Evaluate audit f...