QUALITY ENGINEER

Description

Job Summary: Responsible for reviewing the conditions authorized by Health Ministries and regulatory requirements for soft gelatin capsule products, ensuring compliance with quality standards. Key Highlights: 1. 100% Mexican company with an 80-year history. 2. Opportunity to impact health nationally and internationally. 3. Join a team focused on excellence. **Date:** Mar 25, 2026 **Address:** Carr. a San Isidro Mazatepec 7, JALISCO, MX **Company:** Grupo PiSA Live your purpose and make a difference with Grupo PiSA. With over 80 years of history, Grupo PiSA is a 100% Mexican company committed to the health and well-being of millions of people both in Mexico and internationally. Our growth reflects the effort, passion, and dedication of a team focused on excellence. Join us and become part of a company where every day is an opportunity to live "A Life in Service of Life." Together, we can transform the future of health and leave a positive mark on the world! **Job Objective** To verify that the conditions authorized by Health Ministries for soft gelatin capsule products, as well as regulatory and Good Manufacturing Practice (GMP) requirements, comply with the quality management system to ensure processes meet established quality standards and enhance the production of products and/or services that fulfill the company's established objectives, thereby maintaining compliance to enable distribution and sale of finished products. **Responsibilities** * Conduct and/or coordinate root-cause investigations of issues and generate improvement proposals (internal and external failures), and implement corrective and preventive actions across manufacturing processes, production support areas, critical systems, and other areas to prevent recurrence. * Generate or modify documents while verifying compliance with established conditions and parameters. * Conduct self-inspection walkthroughs to generate reports enabling implementation of corrective actions. * Monitor execution of change controls and administer and monitor complaints. * Perform activities associated with the Quality System under a compliance code for Good Manufacturing Practices (GMPs). * Perform activities related to the sourcing, selection, evaluation, qualification, and deactivation of suppliers of raw materials and services. * Develop, review, and manage the Site Master File, Quality Manual, Contract Manufacturing Notices, and Technical Quality Agreements. Ensure information remains updated and accessible at all times. * Coordinate and participate in the Annual Product Review (APR), communicate results, and manage improvement opportunities. * Actively participate in product market withdrawal processes, whether during simulations or actual events. * Review and safeguard master documents and specifications. Maintain manufacturing records, analytical manufacturing records, and raw material records. * Coordinate and execute quality release decisions for disposition of raw materials, materials, and finished products. **Experience** * Pharmaceutical industry. * Experience managing risk management systems and corrective and preventive actions (CAPA), complaints, and deviations. * Development of document management systems (quality system). **Education** Bachelor’s degree in chemistry or pharmaceutical-related fields (degree required) **Knowledge** * Intermediate Excel (databases, pivot tables, etc.). * Pharmaceutical regulations (NOM-059) At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunity, inclusion, and diversity. Our selection processes are FREE OF CHARGE; report any irregularities to lineaeticagrupopisa@letica.email