Assoc, QA - Batch Release

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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.

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