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Nosotros
Quality Supervisor
Job summary
Una empresa logística global busca un Responsable de Salud para supervisar las operaciones de calidad en su almacén farmacéutico. Deberás asegurar el cumplimiento de las normativas y gestionar el Sistema de Gestión de Calidad. Se requiere un Biólogo Farmacéutico con al menos 2 años de experiencia y dominio del inglés. Este rol te brinda la oportunidad de desarrollar tu potencial en un entorno dinámico.
Qualifications
- Mínimo 2 años como Responsable de Salud o Coordinador de Calidad en la industria farmacéutica.
- Inglés avanzado es esencial.
- Familiaridad con requisitos regulatorios locales y regionales.
Responsibilities
- Mantener el Sistema de Gestión de Calidad (QMS), incluyendo CAPA, Análisis de Riesgos y Control Documental.
- Asegurar el cumplimiento de los requisitos regulatorios para medicamentos y dispositivos médicos.
- Supervisar el manejo de quejas y desviaciones.
Skills
Education
Be the health responsible for the maquila processes of the warehouse operation. Ensure compliance with quality standards and regulations in the operation of the pharmaceutical warehouse by supervising quality management processes and ensuring product integrity.
- Maintain the Quality Management System (QMS), including CAPA's, Change Controls, Risk Analysis, and Document Control.
- Ensure compliance with applicable regulatory requirements for medicines and medical devices, such as NOM 059, NOM 241, and the United Mexican States Pharmacopoeia.
- Follow up on the handling of complaints and deviations, ensuring that corrective actions and effectiveness verifications are implemented.
- Supervise the monitoring of environmental conditions (temperature and relative humidity) and ensure the calibration of instruments.
- Execute and receive audits of the QMS, as well as attend verification visits from the authority (COFEPRIS).
- Release and approve secondary packaging products.
- Execute maintenance of the validated state and equipment qualifications.
- Implement work plans that clearly identify priorities and ensure regulatory compliance.
- Manage and oversee projects, applying problem-solving methodologies and process mapping.
- Education: Pharmaceutical Biologist or similar.
- Experience: Minimum of 2 years as a Health Responsible or Quality Coordinator in the pharmaceutical industry.
- Languages: Advanced English is essential.
- Knowledge: Familiarity with local and regional regulatory requirements applicable to medicines and medical devices.
- Skills: Leadership ability, customer service focus, and desirable experience in warehouse operation startups.
- Competencies: Proficiency in problem-solving methodologies and skills in project management and administration.
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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.