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
