Quality Operations Specialist

hace 1 semana


Xico, México Novartis A tiempo completo

About the Role:

We are seeking a highly skilled Quality Operations Specialist to join our team at Novartis. As a Quality Operations Specialist, you will be responsible for ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:

  • Perform release of all manufactured, packaged, and tested materials, ensuring that all documentation fully adheres to cGMP and data integrity standards.
  • Confirm that all batch records are properly issued and reviewed, and escalate any discrepancies immediately.
  • Assist functional areas in achieving timely and compliant final product disposition.
  • Ensure that specifications are in place and compliant with GMP regulations.
  • Support metric tracking of documentation and release data to ensure continuous improvement.
  • Collaborate with QA Batch Release as a valued business partner, promoting a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
  • Manage CAPA and improve processes within QA Batch Release.

Requirements:

  • Bachelor's degree in Chemistry or a related field.
  • 3-5 years of experience in the pharmaceutical or manufacturing sector, with expertise in GxP operations.
  • Knowledge of GMP regulations and French/Portuguese language skills.

About Us:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



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