Job opportunity for M.Pharm, B.Pharm, MSc as QA Associate @ Baxter -Apply online before 30th January 2024


Website Baxter

About Baxter

Baxter is deeply committed to its mission of improving healthcare and making a positive impact on people’s lives worldwide. The organization’s products and therapies being present in hospitals, clinics, and even homes underscores the extensive reach of its innovations. With a history spanning over 85 years, Baxter’s dedication to pioneering medical advancements demonstrates a strong legacy of transforming healthcare for the better. This sense of purpose within the organization and the global impact of its work are indeed commendable.

Baxter has a significant global footprint, with operations in various countries. This global reach allows the company to contribute to expanding access to healthcare services in both emerging and developed nations.

Job Post: Associate, QA – Batch Release

Job Description:

  1. Review executed Batch Manufacturing Records and Batch Packing Records.
  2. Ensure accuracy, completeness, and compliance with established specifications in batch records for release or reject determination.
  3. Review batch records and data against applicable Technical Package, SOPs, specifications, GDPs, GMPs, and quality parameters.
  4. Address abnormalities observed during batch records review in coordination with respective functions.
  5. Ensure completion and closure of investigations associated with batch records review prior to batch disposition.
  6. Prepare Batch Release Note for compliant batches and Batch Rejection Note for non-compliant batches.
  7. Apply appropriate batch labeling for rejected batches and oversee their relocation in the warehouse.
  8. Ensure adherence to current Good Manufacturing Practice (cGMP) standards.
  9. Issue and generate rejected labels for non-conforming batches.

    10. Periodically verify reject label audit trail report; report discrepancies to Supervisor.                            Additional Responsibilities:

  1. Prepare change control management (CCM) or document change request (DCR) for Batch Release activities.
  2. Raise Non-conformance Reports (NCR) for any non-compliance during Batch Release activities.
  3. Prepare, review, or revise SOPs as needed to meet regulatory requirements or address internal audit observations.
  4. Prepare Certificate of Conformity and Certificate of Manufacturing; submit to PAC/partner as required.
  5. Coordinate with PAC team for QP-related query support as per standard operating procedure.
  6. Support cross-functional staff in resolving Batch records related queries.
  7. Initiate and implement corrective and preventive actions in coordination with respective functions.
  8. Perform execution tasks for Corrective Action, Preventive Action, and Change Control Management.
  9. Submit Batch Release documents to IRA as required; keep supervisor informed of submission status.
  10. Provide entry access to QA office and retain sample room; maintain related documents.

Additional Information:

  • Experience: 2 to 6 years
  • Qualification: M.Pharm, B.Pharm, M.Sc
  • Location: Ahmedabad, Gujarat
  • Industry Type: Pharma/ Healthcare/ Clinical Research
  • Functional Area: QA
  • End Date: 30th January 2024

How to Apply:

Interested candidates meeting the qualifications can submit their resumes to [] by the closing date. Please mention “Associate, QA – Batch Release” in the subject line.

Note: Only shortlisted candidates will be contacted for further assessment.

This job post is designed to attract qualified candidates while providing a clear outline of the responsibilities and requirements for the position.

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