Quality Assurance Associate

hace 4 semanas


Ciudad de México, Ciudad de México Marken A tiempo completo

Job Summary:

The Quality Assurance Associate I (QAA I) is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies. The QAA I also ensures compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate.

Main Responsibilities:

  • Implement, communicate and maintain company's quality systems, in compliance with Marken's Global QMS requirements.
  • Interact with clients on Quality Assurance (QA)/ GxP related matters under management supervision.
  • Effectively interact with Marken Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
  • Support on internal audits.
  • Support client audits and regulatory inspections, including the preparation of appropriate materials required within those audits when applicable.
  • Responsible for the QTA process, including ownership of the QTA from initiation of the QTA template through to final signatures and filing; assigning a QTA # and PRA # if applicable, and assuring compliance to the SOP, including ensuring a QTA is updated or retired appropriately.
  • Collate issues, CAPA, Risk Assessment, Change Control and training metrics and identify quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.
  • Identify relevant GxP/ Quality related training needs and deliver training where required.
  • Ensuring that the Marken Quality System and GxP Program are implemented and maintained.
  • Ensuring the accuracy and quality of records and documents.
  • Participate actively in all the internal Quality and/ or designated meetings.


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