Key Responsibilities:

1. Review executed Batch Manufacturing Records and Batch Packing Records.
2. Ensure every batch record is reviewed for accuracy, completeness, and compliance with established specifications to determine its disposition for release or reject.
3. Review all batch records and data against the requirements of applicable Technical Package, SOPs, specifications, Good Documentation Practices (GDPs), Good Manufacturing Practices (GMPs) and any impact on product quality, strength, identity, safety, purity, and quality prior to batch disposition.
4. Address abnormalities observed during batch records review in coordination with respective functions.
5. Ensure all investigations associated with a batch records review have been completed, adequately investigated, and closed out prior to the batch disposition.
6. Prepare Batch Release Note once the batch complies with pre-defined specifications limits and marketing authorization requirements; prepare Batch Rejection note if not complying.
7. Assure appropriate batch labeling for rejected batches and ensure they are moved to the designated area of the warehouse.
8. Follow current Good Manufacturing Practice (cGMP) standards.
9. Issue and generate rejected labels for rejected batches.
10. Verify reject label audit trail report periodically and inform the Supervisor of any discrepancies.
11. Prepare change control management (CCM) or document change requests (DCR) for Batch Release-related activities.
12. Raise Non-conformance Reports (NCR) for any non-compliance during Batch Release-related activities.
13. Prepare, review, or revise SOPs at regular intervals to meet regulatory requirements or comply with internal audit observations.
14. Prepare Certificates of Conformity and Certificates of Manufacturing as per PAC/partner requirements and submit them.
15. Coordinate with PAC team for QP-related query support as per SOP.
16. Support cross-functional staff for any Batch records-related query resolution.
17. Initiate and implement corrective and preventive actions in coordination with respective functions.
18. Execute tasks for Corrective Action and Preventive Action as well as Change Control Management.
19. Submit Batch Release documents to IRA as required and keep the supervisor informed of the submission status.
20. Provide entry access to QA-office and retain sample room, maintaining its documentation.
21. Ensure sample/batch destruction authorization procedures are performed as required.
22. Prepare time-to-time budget for purchase, purchase order, and good receipt notes for all requirements related to batch release activities.
23. Communicate any failure or abnormality notifications to Supervisor & QA Head for their attention and seeking solutions.
24. Keep status updates of released/rejected batches and report to Supervisor and QA Head daily.
25. Seek areas of improvement from QA Head and prepare an action plan.

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process

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