QUALITY ENGINEER

Description

Position Summary: Ensure regulatory compliance and adherence to good manufacturing and documentation practices for raw materials and finished products. Key Responsibilities: 1. Responsible for master document management and product quality. 2. Coordinates quality evaluations and annual product reviews. 3. Participates in external audits and CAPA follow-up. **Date:** Apr 23, 2026 **Address:** TLAJOMULCO DE ZUÑIGA, JALISCO, MX **Company:** Grupo PiSA **Type of Employee** Trusted **Position Objective** Ensure regulatory and good manufacturing and documentation practice compliance for raw materials and finished products, in accordance with applicable regulatory requirements, through execution of position-specific duties and those inherent to the role of Sanitary Responsible Assistant. **Responsibilities and Activities** * Generate, review, approve, and/or safeguard master documents (monographs, specifications, master production orders, validation documents, master site file, among others). * Coordinate and execute quality evaluations to determine disposition of raw materials, materials, semi-finished products, and finished products. * Manage tracking and disposition of blocked batches. * Coordinate preparation of the Annual Product Review (APR) and its corresponding recordkeeping, as well as manage findings detected during each review cycle. * Host external audits conducted by customers, regulatory agencies, and third parties. * Follow up on Change Controls and CAPAs (Corrective and Preventive Actions) assigned. Experience Development and implementation of quality systems. Knowledge NOM-059-SSA1 (current) Good Manufacturing Practices Education Bachelor’s degree in Chemical-Pharmaceutical, Chemical-Biological, or Chemical-Pharmaceutical-Biological fields **Complementary Profile** Manufacturing processes