Assoc I, Quality Assurance Job at Baxter (Ahmedabad)

Assoc I, Quality Assurance

Baxter

Location:
India , Ahmedabad

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

Save Job

Apply Position

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.

Job Responsibility:

Batch Disposition post reviewing the batch manufacturing, packing, and testing records assuring compliance with established SOP’s, specifications, and standard formats and ensures that all investigations related to batch are closed prior to the batch disposition
Assess the impact of proposed changes & recommended changes for batch release function by providing impact assessment to the change proposals
Identify, investigate, and resolve all discrepancies and non-conformities in the process, systems or documents. Ensure impacted batches are quarantined until disposition
Put on hold the batches impacted by Quality, out of specification, departure from the established procedures and processes, impacted for the causes related to market complaints. Conduct investigation within the quality purview to determine the impact, root cause, and the patient safety of a product identified with departure from established system (Specification, process attributes, market surveillance information)
Identification of batches affected with non-conformance of established quality attributes, followed by movement of batches to rejected area and to ensure destruction of the batches per established procedures. Reconcile the batch and attributed packaging materials with appropriate documentation and traceability
Prepare /submit Certificate of Conformity (CoC) and Certificate of Manufacturing (CoM) as per the requirement of Quality and Business development department. Verify that Serialization data verification in EMV’s is completed before the COC preparation
Control the on-status batch shipment process of Baxter Ahmedabad, by assuring necessary documents associated with on-status release, compliance to the procedure and to establish communication with warehousing under Baxter’s control to provide necessary decision on batch disposition
Report batch released/rejected status to Supervisor/Head QA on daily basis by maintaining a tracker
Support PAC/RA team for quality related query/updates to QP and to provide all necessary information/data through documents
Escalate necessary regulatory/Government related queries, and actions associated with released products and to support the authorities continuously with necessary documentation/updates
Support all compliance, quality related initiations to ensure site is in continuous state of compliance with respect to the products manufactured and released

Requirements:

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 18, 2026

Employment Type:

Fulltime

Work Type:

On-site work

Baxter - All Job Offers

Job Link Share: