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Baxter India Pvt Ltd
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Sr Assoc, Quality - Mkt Complaint

Sr Assoc, Quality - Mkt Complaint

Baxter India Pvt Ltd

0 years

1 - 4 Lacs

Ahmedabad Gujarat India

Posted:13 hours ago| Platform: Foundit logo

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Skills Required

Complaint Management Root Cause Analysis

Work Mode

On-site

Job Type

Full Time

Job Description

To maintain compliance with local needs and global requirements as per defined procedures.
To receive market complaint & share with cross-functional teams (CFT), keep tracking of all received complaints and share status of complaint to concerned cross-functional teams.
To perform & assist the complaint investigation, root cause analysis and its mitigation and associated Corrective and Preventive Action (CAPA), along with CFT members within specified timelines.
To prepare the investigation report and send to respective CFT members for review/approval.
To carry Field Alert Report (FAR) or Quality Defect Report assessment for each received Market complaint, OOS and NCR (if applicable).
To carry risk analysis of received complaint as mentioned in local procedure.
To close the complaint evaluation in Complaint Management System (Trackwise 8) within specified timelines & as per local and global requirement.
To Initiate & handle Document Change Request (DCR), Non-Conformity Report (NCR) or Corrective and Preventive Action (CAPA) as per defined procedure.
To be a part of all internal and external audits and inspections.
To prepare Field Alert Form and Quality Defect report for regulatory submission and communicate with MAH/QP/Country Manager, as applicable for regulatory notification.
To initiate and handle Field Actions (Product/Mock Recall) & related activities in Field Action System (FAS) as specified in local & global procedures.
To initiate and handle Corporate Hold & related activities in Baxter Hold System (BHS) as per defined local & global procedures.
To prepare and revise Standard Operating Procedures in TcU and perform its Gap Assessment with respect to Global Procedure in timely manner.
To Maintain, Archive & Destruct the documents associated with Market Complaint, Field Action (product/mock recall), Field Alert Report/Quality Defect Report, Product Hold as per defined procedure.
To fetch details from Quality Portal in timely manner (as per SOP) & prepare Quality Metrics/Trend Report associated Market Complaints/Field actions/Product Hold/FAR & QDR and share Market Complaint Manager &/or with CFT (as applicable) for review/approval.

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