Sr Assoc, Quality - Supp Quality, Baxter

Sr Assoc, Quality - Supp Quality

Baxter

Location:

India, Ahmedabad

Category:

Quality Control

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

This role involves ensuring compliance with supplier standards and quality regulations, conducting audits, managing supplier-related processes, and addressing risks and gaps. The position offers growth opportunities at Baxter, a company committed to saving and sustaining lives.

Job Responsibility:

To ensure the compliance of Standard Operating procedure of Supplier Qualification and Handling of Supplier Notification of Changes
To complete all activities required for Qualification of supplier including supplier audits as per Standard Operating procedure
To ensure Supplier Maintenance, Supplier Monitoring, requirement review (including quality agreement, certifications, etc.) and Supplier Corrective Action Request as per Standard Operating procedure
To escalate and assess risk of critical findings in supplier audits, regulatory inspection outcome at suppliers Manufacturing site and take steps to minimize the risk
To follow Supplier Audit Procedure and auditor qualifications as per Supplier Audit Procedure
To review and evaluate supplier responses for non-conformances or audit observations
To maintain audit index for tracking of supplier audits and Approved Vendor List
To perform annual evaluation of approved suppliers
To handle non-conformance record (NCR), Corrective and Preventive Actions (CAPA) and Change Control Management (CCM), its activities and closure as per procedure
To prepare & update Standard Operating Procedure (SOP)
To engage in cross functional activities and support cross functions involving supplier related activities
To assess the impact of Out of Specification (OOS), Out of Trend (OOT), Laboratory Investigations (LBINV) and other QMS elements when required
To represent Supplier Quality during regulatory and internal inspections as per need of the organization
To communicate supplier for receipt of market complaint, to get the required information and documents
To identify gaps in procedure as per changes in guidelines
To ensure archival and retrieval of documents
To Coordinate with procurement department for supplier related activates
To ensure the Regulatory and Quality compliance
Implementing continuous improvement initiatives to enhance supplier performance, efficiency, and quality
Monitoring supplier performance against key performance indicators (KPIs) and benchmarks

Requirements:

Bachelor’s/Master’s degree in Pharmacy
10+ years’ broad experience in Supplier Qualification of API, Raw material, Packaging Material, Contact labs and Service suppliers
Qualified Lead auditor
Excellent communication skills and the ability to effectively manage key stakeholders, resolve problems and seek practical solutions
Proficiency in Project Management, Presentation skills and Data Governance

Nice to have:

Hands on experience in material handling tools/ ERP (JDEdwards), document management systems (TcU, CFS, LIMS), Supplier Quality Lifecycle Management (SQLM), Trackwise

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 20, 2025

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