Quality Assurance Engineer

Bayer CropScience Limited; Tlaxcala de Xicohténcatl; Presencial; MXN 300.000 - 420.000; Jornada completa

Descripción de la vacante

Bayer CropScience Limited in Tlaxcala, Mexico is seeking a Quality Assurance Engineer to act as Qualified Person (QP), ensuring GMP compliance and batch release for locally manufactured products. You will perform inspections, monitor processes, investigate customer complaints, and support ISO 9001/14001/45001 certifications through audits and CAPA programs.

The role requires an engineering degree, 3+ years in QA, leadership, regulatory understanding, and English proficiency; the position is

Formación

• Bachelor's degree in engineering (Biochemical, Chemical, Industrial, Process & Design, or similar).
• Minimum 3 years of experience in quality control, QA, or related areas.
• Demonstrated leadership with effective facilitation and communication skills.
• Broad understanding of legal requirements and quality control regulations, standards, and methodologies.
• Proficiency in quality control tools and software.
• English: Intermediate level.

Responsabilidades

• Perform inspections and process documents on products, intermediates, and raw materials to ensure compliance with quality standards and regulatory requirements.
• Monitor and analyze production and processes to identify deviations, trends, defects, and improvement opportunities.
• Maintain and uphold ISO 9001 certification, and support ISO 14001, and ISO 45001 certifications through audits, documentation, and continuous improvement initiatives.
• Maintain the Integrated Management System focused on the quality pillar, improving operational controls and quality assurance protocols.
• Investigate customer complaints, identify root causes, and develop, implement, and monitor CAPA.
• Support Product Supply System (PSS) implementation and continuous improvement initiatives using Lean tools to drive process efficiency, safety, and cost optimization.
• Lead quality training programs for all employees, building a consistent quality culture across the organization, including specialized training for QHSE team members.
• Support technology development and transfer projects in collaboration with business and production functions.

Conocimientos

Leadership

Communication

Quality control

Regulatory knowledge

English (Intermediate)

Educación

Bachelor's degree in engineering

Herramientas

SAP

GMP

GLP

ISO standards

SIG

Descripción del empleo

Quality Assurance Engineer

Serves as the Qualified Person (QP) as required by governing regulations, ensuring the quality and legitimacy of medicinal products. Responsible for maintaining all necessary processes and procedures for QP certification, overseeing batch release, and ensuring compliance with GMP and regulatory requirements for products manufactured in the country. The QP certifies that each production batch meets the required quality standards and documents this certification appropriately.

Job Description

• Perform inspections and process documents on products, intermediates, and raw materials to ensure compliance with specified quality standards and regulatory requirements.
• Monitor and analyze production and processes to identify deviations, trends, defects, and improvement opportunities; generate reports and track KPI performance.
• Maintain and uphold ISO 9001 certification, and support ISO 14001, and ISO 45001 certifications through systematic audits, documentation, and continuous improvement initiatives.
• Maintain and support the Integrated Management System focused on the quality pillar improving operational controls, and quality assurance protocols aligned with internal regulations and legal requirements.
• Investigate customer complaints, identify root causes, and develop, implement, and monitor corrective action plans (CAPA).
• Support Product Supply System (PSS) implementation and continuous improvement initiatives using Lean tools to drive process efficiency, safety, and cost optimization.
• Lead quality training programs for all employees, building a consistent quality culture across the organization, including specialized training for QHSE team members.
• Support technology development and transfer projects in collaboration with business and production functions.

Reporting & Key Relationships

• Internal: Regional and local Partners, Quality Regional & Global Partners, Regional and Global Regulatory Partners.
• External: Government Departments, Laboratory Service Providers, Tollers, Auditors.

Required Qualifications

• Bachelor's degree in engineering (Biochemical, Chemical, Industrial, Process & Design, or similar).
• Minimum 3 years of experience in quality control, quality assurance, or related areas.
• Demonstrated leadership with effective facilitation and communication skills.
• Broad understanding of legal requirements and quality control regulations, standards, and methodologies.
• Proficiency in quality control tools and software.
• Strong results orientation with effective prioritization skills.
• English: Intermediate level.

Technical & Systems Knowledge

• ISO 9001, 14001 and 45001.
• Integrated Management System (SIG)
• SAP
• Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP)
• Official regulations of Mexico

Período de aplicación: 01 al 15 Septiembre

Código de referencia: 882878

División: Crop Science

Ubicación: Mexico : Tlaxcala : Tlaxcala

Área funcional: Calidad

Grado de posición: H

Tipo de empleo: Permanente

Tiempo de trabajo: INDEFINIDO - FULL TIME