Assistant Manager Investigation

Role & responsibilities

• Overall responsible for review of QMS investigations (OOS, OOT, Incidents, CAPA and Product Market complaints), root cause analysis & design uniform Investigation Management System.
• Review of adequacy of CAPA with respect to the root cause investigations.
• Scoring of Investigations independently using 12 elements like; Adequacy of: Problem Statement, Immediate actions, Historical checks, Initial impact assessment, Root cause analysis, Human error evaluation, Root cause conclusion, Impact assessment, Risk assessment evaluation of Regulatory notification, CAPA and CAPA effectiveness check plan, closure timelines etc., ensuring that the investigations were adequately scoped and corresponding CAPA implemented.
• To overview manufacturing operation of all manufacturing blocks, equipment operations as a part of QMS investigations for Baddi-3.
• To assess Manufacturing Training & TNI, design training program and conduct periodic training on procedures related to shop floor compliance, SOP, GMP Audit behavior & GDP.
• To facilitate technology transfer from R&D to extent of robust manufacturing process with taking care of various technical issues.
• Develop compliance culture on shop floor to maintain ATR (All Time Readiness).
• Conduct Internal Audits as per the Planner, review and approval of audit report.