Analista de Estabilidades

About the role

The Stability Analyst will conduct physical‑chemical, microbiological and chromatographic stability studies for new products, reformulations and alternative manufacturer evaluations, ensuring compliance with regulatory requirements and internal quality standards.

Key responsibilities

• Perform stability studies (physicochemical and chromatographic analyses) to determine product shelf‑life for new products, reformulations and alternative manufacturers.
• Document results accurately and maintain compliance with the annual stability program.
• Execute activities in line with Good Manufacturing Practices (GMP) and the company’s quality system.
• Ensure adherence to official regulations and internal company policies.

Required profile

• At least 1 year of experience in the pharmaceutical industry.
• Bachelor’s degree in Chemical‑Pharmaceutical, Chemical‑Biological, or a related field.
• Familiarity with laboratory safety programs and research‑development environments.

Required skills

• Analytical chemistry and chromatographic techniques (GC, LC).
• Operation of laboratory equipment (dissolvers, analytical balances, potentiometer).
• Knowledge of Mexican regulations NOM‑059, NOM‑073, NOM‑249 and Good Laboratory Practices.
• Descriptive statistics (mean, standard deviation, etc.).li>
• Ion balance and chemical stability assessment.
• Quality by Design (QbD) principles.
• Minitab statistical software.
• Microsoft Office 365.
• ERP systems (SAP desirable).