Quality Assurance Specialist

hace 2 semanas


Xico, México Sdz Mex A tiempo completo

Quality Assurance Specialist

Sandoz, a global leader in generic and biosimilar medicines, is seeking a Quality Assurance Specialist to join our team in Mexico. As a key member of our Quality team, you will be responsible for ensuring that all aspects of the handling and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.

Key Responsibilities:

  • Ensure that Change requests are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
  • Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, Follow up the corrective actions. Archive relative documentations.
  • Coordinate implementation of quality system and procedures for the implementation of Novartis Quality Manual and quality agreements.
  • Ensure that all incoming drug products are inspected prior to release to the market in accordance with the current in place procedures, registered specifications and with local/international regulations.
  • Manage complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures.

Requirements:

  • Operations Management and Execution
  • Collaborating across boundaries
  • Functional Breadth
  • Participating in volunteer / community projects
  • English Regulations & Guidelines
  • Knowledge of CAPA
  • Good Documentation Practice
  • Quality Management
  • Quality Assurance

What We Offer:

  • Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

Why Sandoz?

Sandoz, a leader in generic and biosimilar medicines, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more. 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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