MS&T - MIT

• Job description for Manufacturing Investigation Team (MIT) : 1.
• Shall be responsible for enforcement of processing engineering and statistical assessment for the investigation across sites.

Responsibilities

• Shall be responsible for handling Quality events like out of specification (OOS) and Out of trend (OOT) cases.
• 2.
• Shall be responsible for the execution of Phase-II (Process investigation pertaining to all applicable manufacturing unit operations) at dosage form manufacturing facilities.
• 3.
• Shall perform thorough review of Phase-I/ Analytical investigation reports to understand the nature of failures.
• Shall witness QC hypothesis for OOS/OOT investigations as and when required as a part of Phase II investigations recommendation.
• 5.
• Shall perform Root Cause Analysis for OOSs/OOTs observed for solid dosage form (Data driven scientific rationale for RC/ Brainstorming with Analyst, Operator & all Doers involved in the mfg. & testing of subjected batch failure).
• Shall implement and trained on applicable Analytical/ Statistical tools to have appropriate root cause analysis.
• Shall document applicable raw & meta data as a part of investigation to support root cause analysis.
• Shall review BMR, BPR, Lab records, Stability data, PDRs, Engineering batch data, PPQ/ CPV, Quality Risk Assessment and Tech Transfer documents as applicable.
• Shall coordinate with CFT for the implementation of corrective and preventive actions (CAPA).
• Shall prepare investigation report with all supporting data.
• Shall prepare Protocols, SOPs as applicable as a part of CAPA recommendations.
• Shall monitor the Engineering/ Commercial bx in shop floor as a part of RCA & CAPA effectiveness checks.
• To do fore cause audit of RM vendors as a part of RCA to the mfg. investigations.
• Shall execute trend analysis of CMAs (Critical Material Attributes), CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) by using statistical tools as appropriate.