Documentation Analyst

Description

Job Summary: We are seeking a Pharmaceutical Documentation Analyst to control and manage documentation, ensuring regulatory compliance and quality within the pharmaceutical industry. Key Highlights: 1. Key role in pharmaceutical documentation management and regulatory compliance. 2. Opportunity to apply knowledge of GDP, GMP, GLP, GPP, and NOM-059. 3. Focus on analysis, synthesis, and problem-solving in quality. A well-established Mexican pharmaceutical group with over 46 years in the pharmaceutical market. We seek your talent as: **PHARMACEUTICAL DOCUMENTATION ANALYST** **Requirements:** * Education: Bachelor's degree in Pharmacy and Biochemistry, Chemistry and Pharmacy, Biomedical Engineering, Food Engineering, or related field. * Experience: Minimum 1 year as a documentation analyst chemist in the pharmaceutical industry. * Knowledge of GDP, GMP, GLP, GPP, NOM-059, etc. * Minimum 1 year of experience in handling and controlling documentation required by current regulations and managing product dossiers. * **Mandatory proficiency in Statistics and Change Controls related to modifications of any documentation associated with the manufactured product.** * **Mandatory proficiency in Excel (90% level)** * Analytical, synthetic, and timely problem-solving capabilities. * Service-oriented attitude: Maintain constant communication with related departments and supervisors. * Follow up on any out-of-specification results, deviations, or quality risks. * Comply with the Quality Management System, standards, policies, and safety, hygiene, and environmental protection measures. * Verify that documentation is accurate and traceable. **We Offer:** ° Salary: $12,200.00 ° Statutory benefits: vacation, year-end bonus, etc. ° Additional benefits including savings fund, food vouchers, and subsidized cafeteria service. Working hours: Monday to Saturday, 9:00 AM to 6:00 PM. Work location: Tlalpan, CDMX, 5 minutes from Estadio Azteca.