Químico de documentación técnica y proyectos

Job Description

Manage, review, and safeguard the documentation generated in Research and Development for the integration of technical dossiers for medicines and medical devices (new registrations and modifications).
Ensure compliance with national and international standards, pharmacopoeias, and guidelines, coordinating with internal and external multidisciplinary areas during development.
Manage and validate the translation of required technical documentation, ensuring its integrity compared to the original documents.
Prepare technical justifications and respond to requests from health authorities regarding technical dossiers.
Verify calculations in formulation documentation, analytical development, validation, and stability studies.
Assign codes and manage documentation and procedures related to technical dossiers and project administration.
Define, plan, and monitor project activities, timelines, milestones, and responsible parties using schedules, identifying the critical path and ensuring its completion.
Maintain up-to-date schedules, presentations, and project and technical dossier tracking dashboards.

Qualification and Experience

Pharmaceutical Chemist, Pharmaceutical Engineer, Chemical Engineer, Pharmaceutical Engineer, or related field
Diploma or course in preparing technical dossiers for new registrations or MCRs according to ICH guidelines
M4 - CTD
Knowledge of NOM 059, NOM 242, NOM 073, NOM 072, ICH Quality Guidelines, and E6
Diploma or course in project management, PMI methodologies, or agile methodologies

Problem-solving, attention to detail, teamwork, assertive communication, project management, strategic relationship building

3 years of experience in preparing national and international dossiers (CTD format)
1 year of project management experience
3 years of experience in the pharmaceutical industry

Competencies