Ztmp - QA Investigation

2 weeks ago


Ankleshwar, India Zydus Group Full time

Department
- ANKLESHWAR QA -U1
- Job posted on
- May 27, 2025
- Employment type
- P-P7-Probationer-HO Staff

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

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

**Key Job 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.


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