- 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.

📌 Sr Assoc, Quality - Mkt Complaint (Ahmedabad)
🏢 Baxter India
📍 Ahmedabad