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Team Member - SIT (Quality Control)

3 - 6 years

10 - 20 Lacs

Posted:9 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing.

To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing.

To review level 1B incidents and give feedback for improvement.   

To periodically trend level 1A incidents and highlight/escalate key observations. 

To review any other referred reports associated with incidents/events in association with sites.

To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause.

To use Rubrics template for investigation report writing.

To provide appropriate support to site in preparing for or during regulatory inspection for investigations. 

Qualification

looking someone with strong QC investigation background, QC Compliance, Analytical development
Education :B.Pharm, M.Sc, M.PharmExp : 8-10 YearsIndustry : OSD preferred/ Injectable, API also work

Additional Information

About the DepartmentGlobal Manufacturing Organisation (GMO)

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