Quality Supervisor
hace 1 semana
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.
Key Responsibilities:- 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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