STABILITY ANALYST

Description

Job Summary: Conduct stability studies (physicochemical, microbiological, and chromatographic analyses) for new products and reformulations in the pharmaceutical industry. Key Highlights: 1. It is part of a Mexican company with over 80 years of history. 2. It contributes to the health and well-being of millions of people. 3. An opportunity to live "A Life in Service of Life." 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 impact on the world! **Job Objective** Conduct stability studies (physicochemical, microbiological, and chromatographic analyses) in compliance with regulatory requirements, ensuring the quality of New Products (NP), Reformulations (RF), and Alternate Manufacturer Evaluations (AME), as well as accurate documentation of results, to fulfill the program and objectives established by the Business Unit. **Responsibilities and Activities** * Conduct stability studies (physicochemical and chromatographic analyses) to evaluate stability samples from the New Product Development (NP), Reformulation (RF), and Alternate Manufacturer Evaluation (AME) areas. * Perform activities associated with the Quality System under a code of compliance with Good Manufacturing Practices (GMPs). * Receive stability samples and perform corresponding analyses using laboratory instruments and equipment according to SOPs and/or manuals or monographs included in the analytical dossier. * Report results in the system and follow up on any out-of-specification results, investigating root causes and implementing preventive actions (CAPAs) to prevent recurrence. * Participate in investigations of deviations assigned to your area of responsibility and execute activities to establish action and improvement plans that eliminate the failure, as well as implement them by the committed deadlines. **Experience** * Pharmaceutical industry. * Operation of laboratory equipment and instruments (dissolution testers, analytical balances, potentiometers). * Product stability studies. **Knowledge** * Analytical chemistry and chromatographic techniques. * NOM-059, NOM-073, Good Laboratory Practices. * Descriptive statistics (mean, standard deviation, etc.). * Gas and liquid chromatography. **Education** Bachelor's degree in chemical-related fields: QFB-Pharmacy, Chemical Engineering, Food Engineering, or related disciplines. **Additional Profile Requirements** Valid student internship letter (Carta Pasante) is mandatory. Availability to work rotating shifts. Proficiency in Office 365. At Grupo PiSA, we prohibit violence and discrimination, promoting equal opportunities, inclusion, and diversity. Our selection processes are FREE OF CHARGE; please report any irregularities to lineaeticagrupopisa@letica.email Employment Type: Full-time, Indefinite-term contract Salary: $15,000.00 - $18,000.00 per month Benefits: * Savings fund * Employee discount * Discounts and preferential pricing * Life insurance * Discounted cafeteria service * Grocery vouchers Application Question(s): * Do you have experience in stability studies? Work Location: On-site employment