Validation Analyst

Description

Position Summary: We are seeking a professional to conduct equipment, system, and process validation studies, ensuring regulatory compliance and quality within the pharmaceutical industry. Key Highlights: 1. Conduct equipment, system, and process validation studies 2. Ensure compliance with regulations in the pharmaceutical industry 3. Identify and address process deviations 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 impact on the world! 1\. Responsibilities: 1\.1\. Conduct equipment, system, and process validation studies according to technical specifications and current regulations. 1\.2\. Ensure equipment operates under appropriate conditions, complying with operational and maintenance specifications. 1\.3\. Ensure all documentation complies with applicable regulatory and statutory requirements, and maintain its validity through detailed validation activity reports. 1\.4\. Identify failures to meet protocol acceptance criteria and/or deviations from evaluated processes, and address them for closure. 1\.5\. Ensure validation is performed in accordance with established procedures to meet pharmaceutical industry quality standards and regulations. 2\. Knowledge. 2\.1\. In qualification/validation of areas, systems, equipment, and processes. 2\.2\. In pharmaceutical industry facility processes and designs. 3\. Experience. 3\.1\. Knowledge of national and international pharmaceutical regulations. 3\.2\. Descriptive and inferential statistics for data analysis and process performance estimation. 4\. Education. 4\.1 Bachelor's degree in Pharmaceutical Chemistry and Biology, Chemical Engineering, Mechatronics Engineering, or related field. Proof of graduation (transcript, diploma, or professional license) is mandatory. At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunities, inclusion, and diversity. Our selection processes are FREE OF CHARGE; report any irregularities to lineaeticagrupopisa@letica.email Benefits: * Savings fund * Grocery vouchers Workplace: On-site employment