Assoc, QA - Batch Release_AMD

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Key responsibilities & authorities

Tasks:

Review batch manufacturing, packing, and testing records to ensure compliance with SOPs, specifications, and standard formats. Close all investigations related to the batch before making a disposition.

1. Assess the impact of proposed changes and recommended changes for batch release functions by providing a comprehensive 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.

1. Temporarily pause batches affected by Quality issues, deviations, or non-compliance. Investigate quality-related incidents to assess their impact, root cause, and impact on patient safety.

Identify batches affected by non-conformance of established quality attributes, followed by movement of batches to the rejected area, ensuring destruction per established procedures. Reconcile the batch and attributed packaging materials with appropriate documentation and traceability.

1. Prepare and submit Certificates of Conformity (CoC) and Certificates of Manufacturing (CoM) as the need arises by the Quality and Business Development departments. Verify that serialization data verification in EMVs is completed before CoC preparation.

Supervise the on-status batch shipment process at Baxter Ahmedabad by ensuring that the required documents for on-status release are aligned with procedures. Maintain communication with the warehouse to make vital decisions on batch disposition.

1. Report batch release/rejected status to Supervisor/Head QA daily by maintaining a tracker.

Support the PAC/RA team for quality-related queries and updates to QP, providing all vital information/data through documents.

1. Advance any vital regulatory/government-related queries and actions associated with released products, and consistently provide authorities with required documentation/updates.

Support all compliance and quality-related initiatives to ensure the site is in a continuous state of compliance with respect to the products manufactured and released.

Qualifications & requirements

• Bachelor’s degree in Science, Pharmacy, or related field.
• At least 2 years of experience in a Quality Assurance role within the pharmaceutical or healthcare industry.
• Outstanding understanding of GMP, regulatory guidelines, and quality management systems.
• Proven record to identify, investigate, and resolve discrepancies and non-conformities.
• Strong interpersonal skills and the ability to collaborate optimally across departments.
• Diligent in ensuring high standards of accuracy and compliance.
• Ability to successfully implement quality assurance processes and improvements.

Join us at Baxter Healthcare Corporation and become part of a team committed to delivering special healthcare solutions. Together, we can build a detailed future for healthcare.

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, please click on the link here and let us know the nature of your request along with your contact information.

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