QA Investigation - Quality Assurance

Zydus Lifesciences

3 - 6 years

2 - 3 Lacs

Anklesvar Ankleshwar

Posted:17 hours ago| Platform:

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Skills Required

Investigation Vigilance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Great Opportunity to work withs us in QA - Investigation team .

Role & responsibilities

Handling of the deviation, OOS, OOT, Market complaint, Lab incident, CAPA.

Handling of audits and compliance.
Shop floor investigation to identify the root cause.
To form CFT for investigation and lead the investigation.
To review an investigation plan.
To provide necessary information and data for the investigation.
To ensure investigation is completed within time line.
If investigation is not completed in time, to ensure Interim Report is prepared, reviewed and request for extension is approved by QA head.
To prepare and review investigation report and cause or probable cause for finding cause of failure.
Discuss the findings and improvement areas based on trend analysis in Quality Review Meetings. Preparation, review and approval of trend analysis reports.
Identification of improvement areas based on trend analysis report and providing feedback to the site management.
To propose an investigation plan and evaluation of the impact of failure on already distributed batches, batches under manufacturing or in staging/ Process area.
To find out root cause or contributory factor for most probable root cause.
To carry out impact assessment and risk assessment.
To notify the other functional head to carry out investigation

Preferred candidate profile

Qualification should be M.Sc. Organic chemistry/ PhD with organic chemistry.

Person shall be 3-5 year experience in PD Lab/ R&D/QA

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