Sr Assoc, Quality - Mkt Complaint

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

• 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.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.