11) Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc. 12) Reviews and approves technical quality engineering documentation such as Event, OOT, OOS, and complaint investigations, ensuring adequate root cause analysis as well as identification and implementation of corrective and preventative actions (CAPA).