Quality Operations Specialist (Products Release)
Novartis
Operations, Quality Assurance
Mexico
Posted on Friday, May 26, 2023
28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
Your responsibilities include, but are not limited to:
• Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
• Controlled issuance of batch records in preparation for manufacturing.
• Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
• Assist functional areas with achieving timely and compliant final product disposition of the product.
• Ensure Specifications in place and are within GMP compliance.
• Support metric tracking of documentation and release data to ensure continuous improvement.
• Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
• CAPA management as well as improving processes within QA Batch release. The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
Your responsibilities include, but are not limited to:
• Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
• Controlled issuance of batch records in preparation for manufacturing.
• Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
• Assist functional areas with achieving timely and compliant final product disposition of the product.
• Ensure Specifications in place and are within GMP compliance.
• Support metric tracking of documentation and release data to ensure continuous improvement.
• Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
• CAPA management as well as improving processes within QA Batch release. The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
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