Analista de Validación

Responsibilities

• Plan and execute scientific studies to validate facilities, services, equipment, computer systems, and manufacturing processes.
• Conduct quality system activities in strict compliance with Good Manufacturing Practices (GMP).
• Plan assigned qualifications and validations, executing tests defined in authorized protocols and analyzing results.
• Follow up on identified deviations and provide technical support to Engineering and users for new installations or processes.
• Perform validations for computer systems and spreadsheets.

Requirements

• Bachelor's degree in a relevant scientific or technical field.
• Minimum of 6 months of experience in the validation of processes, areas, services, equipment, or systems.
• Experience within the pharmaceutical, food, cosmetic, or medical device industries.
• Strong knowledge of Good Manufacturing Practices (NOM-059, FDA, Health Canada).
• Proficiency in MS Office (Word, Excel, PowerPoint).
• Knowledge of descriptive and inferential statistics.
• Understanding of technical fundamentals regarding equipment operation, design, and processes.

Preferred Qualifications

• Experience with pharmaceutical manufacturing processes and facility design.
• Experience performing physicochemical and microbiological analyses.
• Knowledge of international and national pharmaceutical regulations, including ISO 13485, NOM 241 SSA2, and 21 CFR 820.

About the Company

Grupo PiSA is a 100% Mexican company with over 80 years of history, committed to the health and well-being of millions of people both in Mexico and internationally. We operate under the philosophy of "A Life at the Service of Life," focusing on excellence and innovation in the healthcare sector.