Senior Section Lead, Market Complaint Job at Baxter (Ahmedabad)

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

Baxter - All Job Offers

Select Country

Senior Section Lead, Market Complaint

Job Description

Requirements

Nice to have

What we offer

Looking for more opportunities?

Senior Section Lead, Market Complaint

Chef De Cuisine (Asian)

Chief Systems Engineer - Surveillance Products

Traveling Dentist – Nursing Home Care

Shift Supervisor

Commercial Operation Specialist

Analyst Credit and Collections

Traveling Dentist – Nursing Home Care

Store Associate

Our AI answers in your language