<ul><li>Conduct thorough investigations of deviations, non-conformances, OOS (Out of Specification), and OOT (Out of Trend) results.</li><li>Analyze root causes using scientific and systematic approaches like RCA, 5-Why, or Fishbone analysis.</li><li>Prepare detailed investigation reports with findings, conclusions, and corrective/preventive actions (CAPA).</li><li>Ensure investigations comply with GMP, regulatory requirements, and internal SOPs.</li><li>Collaborate with QC, production, and R&amp;D teams to collect necessary data and samples.</li><li>Track and monitor the implementation and effectiveness of CAPA actions.</li><li>Maintain proper documentation and audit-ready records of all investigations.</li><li>Identify trends and suggest process improvements to minimize recurrence of deviations.</li><li>Support internal and external audits by providing investigation reports and follow-up actions.</li></ul>

Quality Assurance Executive (Investigation)