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Senior Section Lead, Market Complaint

https://www.baxter.com/ Logo

Baxter

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Location:
India , Ahmedabad

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Requirements:

  • Monitoring compliance to local and global requirements as defined in the procedures of Market Complaint, Field Action function
  • Ensure market complaint investigations and related activities are completed as per specified timelines in procedures
  • Collaborating with sub-functional and functional leaders across the company for market complaint related investigation
  • Support the Field Actions (Product/Mock Recall) & Corporate Product Hold & related activities
  • Review / Approve the Field Alert Report (FAR) or Quality Defect Report (QDR) assessment & communicate to external stakeholders/partners for regulatory notification (as applicable)
  • Ensure that QMS elements such as Document Change Request (DCR), Change Control Management (CCM) or Non-conformity (NCR) and Corrective and Preventive Action (CAPA) related to function are processed and closed appropriately
  • Conducts market complaint trending including review of investigation reports
  • Monitor that all the function related KPIs & targets are met, as per requirement
  • Facilitates professional development, training, for functional Staff
  • Escalate the non-compliances (if any) observed with the resolution proposals for discussions with the Department of Head
  • To be the part of all internal and external audits and inspections and prepare the response of observations raised during regulatory inspections associated with Market Complaint and retain sample with Audit & Inspection team
  • Ensuring data is provided for data for Audit(s)
  • To monitor and plan day to day activities related to Retain Sample (RS) management on day-to-day basis and to communicate the challenges, updates, compliance levels to Head of Department
  • Responsible to drive the continuous improvement plans with Head Quality and cross functional partners, and to ensure all time readiness of the facility in response to the regulatory Inspections
  • Ensure end to end process of retain sample management - ensuring the facility of storage in state operation for intended usage, qualification, and necessary modification
  • Review global procedure and update local procedure as and when required
  • Review manufacturing out of Specification (OOS) and Out of Trend (OOT) report and support in investigation
  • Ensuring trend preparation of Market complaint / LBINV elements as per the frequency
  • To allocate work to the team and ensure the co-ordination within team and across cross functional team

Nice to have:

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 13, 2026

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