Quality Assurance Manager – Careers at Nestlé – Mexico City.

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Exploreture
  • Post Date: October 2, 2021
  • Applications 0
  • Views 153
Job Overview

Quality Assurance Manager

Quality Assurance Manager

A day in the life of…

• Develop regulatory strategies to obtain the approval of new registries, as well as propose strategies for the handling of Modifications to the Registration Conditions and Extensions of the Sanitary Registry for the maintenance of sanitary registries. The time for each activity will be defined by the person in charge, since the time assigned to each one of them depends on how they manage their activities.

• Responsible for conducting and verifying the review of the legal, technical and clinical documentation provided to ensure compliance with local regulations.

• Carry out and verify the correct compilation and preparation of the Product Registration Dossiers before sending them to COFEPRIS.

• Supervise the activities to carry out the IPS, Pharmacovigilance Reports and Risk Management Plans of the products in accordance with the requirements and times specified by the Health Authority.

• Ensure the activities necessary for the Pharmacovigilance Training of the Company’s Personnel.

• Ensure that the Processes and Standards are followed within the External Quality Manufacturing in order to better support the business needs regarding suppliers and products from a QA point of view.

What will make you successful

  • Regulatory processes for obtaining new registries, modifications to the conditions of technical and administrative registry and extensions of the sanitary registry for the maintenance of sanitary registries.
  • Pharmacovigilance requirements for drugs according to NOM-220, Installation and operation of pharmacovigilance
  • Activities for the Release of Medicines and Analytical Transfers.
  • Activities to carry out Stability Studies – use of Stability Studies carried out abroad.
  • Documentation management (procedure, quality formats)
  • Implementation and monitoring of the Quality Management System
  • Preparation of Annual Product Reviews and Quality Management Review.
  • Requirements for medical devices in accordance with NOM-240-SSA1-2012, Installation and operation of technovigilance.
  • Implementation of requirements of NOM 059, NOM 164 and COFEPRIS.
  • Advanced English.

 

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Job Detail
  • Offered SalaryNot Specified
  • Career LevelManager
  • ExperienceNot Specified
  • GenderBoth
  • INDUSTRYManufacuring/Production
  • QualificationBachelor's Degree
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