Quality Management System Analyst.

Description

**JOB OBJECTIVE** Contribute to the consolidation of a robust and standardized Quality Management System (QMS) through implementation, documentation tracking, and methodological support to ensure regulatory compliance, risk mitigation, and continuous improvement. Ensure standardization, maintenance, and enhancement of the Quality Management System, guaranteeing that business units and warehouses operate under standardized guidelines in accordance with applicable current regulations. **RESPONSIBILITIES** * Manage the Document Management System (master list, version control, retention periods, etc.) * Collect information for developing QMS documents. * Track deviations, non-conformities, and corrective actions. * Support root cause analysis and improvement plans. * Accompany external audits (customers, certifications, health authority) as well as internal audits. * Generate reports, track findings, and action plans. * Control attendance records and evaluate training effectiveness. * Support risk management activities. * CAPA. * KPI management. * Promote a culture of Good Documentation Practices within the organization. * Assist in implementing quality process improvements. * Support administrative activities of the department. * Prepare and deliver QMS-related training materials. **POSITION PROFILE** **Education** Bachelor’s degree in Pharmacy (Q.F.B.), Industrial Pharmacy (Q.F.I.), Chemistry (I.Q.), or a related field in the Pharmaceutical or Management Systems sector (degree completed). **Specific Position Knowledge** * ISO 9001:2015\. * NOM\-059\-SSA1\. * Pharmacopoeia supplement. * Risk management. * CAPA. * Document control. * Handling of deviations and non-conformities. * Audits. **Experience** 2 years in the pharmaceutical sector (preferred): * Implementation of Management Systems. * Risk management. * Use of analytical tools. * Good Documentation Practices, storage, and distribution. * Basic knowledge of health regulations. **Software Knowledge** Microsoft Office suite. AI (preferred). **Languages** Intermediate (preferred). **Other** **Skills and Competencies:** * Organization. * Effective communication. * Attention to detail. * Proactivity. * Responsible handling of sensitive and confidential information. * Teamwork. **Indicators:** % progress in QMS implementation. % of currently valid controlled documents.