Assoc 1, Quality Assurance (Baxter)

Roles and Responsibilities

Here, you will find more than just a job—you will find purpose and pride.

1. 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.

2. Assess the impact of proposed changes & recommended changes for batch release function by providing

impact assessment to the change proposals.

3. 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).

5. 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.

6. 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.

7. 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.

8. Report batch released/rejected status to Supervisor/Head QA on daily basis by maintaining a tracker.

9. Support PAC/RA team for quality related query/updates to QP and to provide all necessary information/data

through documents.

10. Escalate necessary regulatory/Government related queries, and actions associated with released products

and to support the authorities continuously with necessary documentation/updates.

11. Support all compliance, quality related initiations to ensure site is in continuous state of compliance with

respect to the products manufactured and released.