Job description for Manufacturing Investigation Team (MIT) :
1.
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.
4.
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).
6.
Shall implement and trained on applicable Analytical/ Statistical tools to have appropriate root cause analysis.
7.
Shall document applicable raw & meta data as a part of investigation to support root cause analysis.
Quality Risk Assessment and Tech Transfer documents as applicable.
9.
Shall coordinate with CFT for the implementation of corrective and preventive actions (CAPA).
10.
Shall prepare investigation report with all supporting data.
11.
Shall prepare Protocols, SOPs as applicable as a part of CAPA recommendations.
12.
Shall monitor the Engineering/ Commercial bx in shop floor as a part of RCA & CAPA effectiveness checks.
13.
To do fore cause audit of RM vendors as a part of RCA to the mfg. investigations.
14.
Shall execute trend analysis of CMAs (Critical Material Attributes), CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) by using statistical tools as appropriate.
15.
Shall be responsible for enforcement of processing engineering and statistical assessment for the investigation across sites.
Job Snapshot
Updated Date
21-10-2026
Job ID
JOB10911
Division
GOA
Location
Manufacturing-formulation|for. Mfg. Goa, Panjim, Goa, India
Experience
5 - 10 Years
Employee Type
P-P8-Probationer-HO Executive
📌 MS&T - MIT (Panaji)
🏢 Zydus Lifesciences
📍 Panaji
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