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 healthcare and leave a positive mark on the world! Ensure regulatory compliance for activities related to purchasing, production, packaging, analysis, validation, storage, and distribution of products carried out at the plant, in accordance with the master documents of the Quality Management System, and define the strategy for executing activities within the Compliance, Operations, and Quality Control departments. **1\.** **Main job responsibilities:** * Ensure that authorized operating procedures under their responsibility are aligned with applicable regulatory requirements, corporate policies and directives, as well as Good Manufacturing Practices, and ensure these remain current during operations. * Establish controls and verify the integrity of information and data generated in the documentary chain of systems that are part of their responsibilities. * Ensure proper retention of documents related to drug manufacturing in accordance with current regulations and, when applicable, international regulations (manufacturing records, analytical records, raw material records, logbooks). * Ensure that all areas of the quality control laboratory involved in the analysis of raw materials (active and excipients), bulk products, and finished products perform testing using previously validated or verified (when applicable) analytical methods, current reagents, certified or suitable laboratory supplies, qualified and/or calibrated equipment, specifications aligned with the authorized conditions of the health registration for each product, and using approved monographs aligned with relevant Pharmacopoeias. * Lead appropriate investigations within their laboratory units for Out-of-Specification (OOS) results to identify root causes, conducting investigations requiring expanded sampling plans. 2\. **Education level:** * Bachelor's degree in chemical sciences: Pharmacy & Biochemistry, Chemical Engineering, Food Science or related field (Degree and professional license) 3\. **Experience:** * Pharmaceutical industry (Mandatory) 4\. **Knowledge:** * FDA: 12 CFR 21, 210 and 211 * Investigating Out-of-Specification (OOS) * Test Results for Pharmaceutical Production Guidance for Industry Guideline * ICH: Q1A-Q1F, Q2, Q3A-Q3E, Q6, Q10, Q14 * EMA At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunities, inclusion, and diversity. Our selection processes are FREE of charge; report any irregularities at lineaeticagrupopisa@letica.email Job type: Full-time Benefits: * Company car * Discounts and preferential prices * Company parking * Medical expense insurance * Cafeteria service * Company phone * Grocery vouchers Workplace: On-site