Coordinador de Operaciones de Calidad de la Afiliada

Overview

States considered : Ciudad de México

Role Description

The Affiliate QO Coordinator is located within Mexico Zoetis Country Office for specific markets responsibilities relating to oversight of product quality activities and associate GMP / GDP activities. In addition, he / she will carry out all supporting activities required to meet legally defined requirements of the licencing bodies. He / She is responsible for the Quality Management System (QMS), ensuring its use and its ongoing suitability for the business and GMS. The Affiliate QO Coordinator is also responsible for developing and maintaining the site Quality Manual in Veeva Vault, site quality system policies, procedures and quality records to comply with local QMS requirement and harmonized with the global QMS. The Affiliate QO Coordinator will oversee Quality matters and provide expert advice and direction to the business and the country Leadership Team. This function supplements any local or statutory Quality activities or requirements. The holder of this role is part of the Regulatory and Quality Leadership Team, helping to manage the business area’s functioning, developing the strategic focus for the team and generate new ideas to move the business forward, improve efficacy and maintain legal compliance.

Main Responsibilities

Quality Assurance

• Quality System Implementation & Management Oversight
• Be the Affiliate QO for Mexico, CAMCar and Colombia; the nominated contact person located in Mexico, for any Quality related issues as required by Zoetis GMS
• Monitor, review the performance of the QMS with SCL QO. Act to assure its maintenance, continued suitability and implement any improvements needed
• Ensure colleagues are appropriately trained on all necessary
• Routine in Country Quality Activities and deviation management
• Investigation and resolution of Product Quality and Compliance Related Issues
• Temperature excursion escalation
• Stop distribution, Recalls
• Change management
• Contractor Quality Oversight (where managed by Zoetis Mexico, CAMCar and Colombia Markets)
• Monitor and Communicate local MoH Requirements
• Ensuring audit readiness and hosting GQCA auditors on country Zoetis Affiliates audits.
• Development and Maintenance of Consistent Quality Culture
• Perform QM setup and approval for SAP Item Master setup using MDG tool
• Perform QA releases of Zoetis Products to the market, using SAP and corresponding systems in Mexico and Colombia.
• Ensure all SAP actions are planned, monitored and executed for the business.
• Attend Quality meetings for critical product quality issues, representing the businesses
• Prepare required documentation for product quality complaints that require Quality / market action
• Lead the Zoetis action to address product quality or compliance issues identified when the product is distributed in the market.
• Audit suppliers to assure continued fitness for provision of goods and services to Zoetis.

Compliance

Relationships

Qualifications (Training, Education & Prior Experience)

Education :

Experience :

Skills

Other Commentaries

English level : Bilingual efficiency (Spanish and English) as a minimum

Preferred place of residence : Ciudad de México

Full time

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