Quality Assurance Specialist-QOP Analyst Product Release

hace 3 semanas


Xico, México Novartis A tiempo completo

We are seeking a quality assurance specialist to support our QOP Analyst Product Release team. This is an exciting opportunity to join a dynamic and collaborative environment where you will play a crucial role in ensuring the quality and integrity of our products.

As a quality assurance specialist, you will be responsible for administering quality systems, including documentation, metrics, and monitoring of actions. You will also perform release of all manufactured, packaged, and tested materials, confirming that all documentation supporting these releases fully adhere to cGMP, including data integrity. Additionally, you will ensure timely escalation to management of all applicable incidents and assist functional areas with achieving timely and compliant final product disposition of the product.

Key Responsibilities:

  1. Release of Manufactured Materials: Perform the release of all manufactured, packaged, and tested materials, ensuring that all documentation supporting these releases is fully compliant with cGMP and data integrity standards.
  2. Documentation and Metrics: Administer quality systems, including documentation, metrics, and monitoring of actions to ensure timely and compliant final product disposition.
  3. Incident Management: Ensure timely escalation to management of all applicable incidents and assist functional areas in achieving timely and compliant final product disposition.

Requirements:

  • Education: Bachelor's degree in Chemistry or a related field.
  • Experience: 3-5 years of experience in the pharmaceutical or manufacturing sector in an analytical lab in a GMP environment or equivalent.
  • Expertise: GxP operations and knowledge of GMP regulations.

About the Role:

This is a full-time regular position with a regular shift and no early talent component. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join Novartis and contribute to our mission to reimagine medicine and improve human health.



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