<ul><li>Conduct detailed investigations of deviations, complaints, OOS (Out of Specification), and OOT (Out of Trend) results.</li><li>Identify root causes using scientific and structured methodologies (RCA, 5-Why, Fishbone).</li><li>Prepare comprehensive investigation reports with findings, conclusions, and recommended CAPA (Corrective and Preventive Actions).</li><li>Ensure all investigations comply with GMP, internal SOPs, and regulatory requirements.</li><li>Collaborate with QC, production, and R&amp;D teams to gather data, samples, and evidence.</li><li>Track, monitor, and verify the implementation and effectiveness of CAPA actions.</li><li>Maintain accurate, complete, and audit-ready documentation of all investigations.</li><li>Identify trends and suggest process or quality improvements to prevent recurrence.</li><li>Support internal and external audits and inspections by providing investigation records and follow-up actions.</li></ul>

Quality Assurance Officer (Investigation)