Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations.
Ensure proper investigational tools are used to systematically define the root cause(s) and contributing factor(s) (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.). To define appropriate CAPA(s), and associated Effectiveness Checks, as solutions to correct deviations and prevent future recurrence.
Ensure cGMP compliance through the investigation process, and to drive their quality records to completion...