Description
SCOPE:
Ensure standardization, maintenance, and improvement of the Quality Management System, guaranteeing that business units and warehouses operate under harmonized guidelines in accordance with applicable current regulations.
GENERAL PURPOSE OF THE POSITION:
Contribute to the consolidation of a robust, harmonized corporate Quality Management System through technical execution, documentary tracking, and methodological support to ensure regulatory compliance, risk mitigation, and continuous improvement.
RESPONSIBILITIES
✓ Administration of the Document Management System (master list, version control, retention periods, etc.)
✓ Collection of information for developing QMS documents.
✓ Tracking of deviations, non-conformities, and corrective actions.
✓ Support in root cause analysis and improvement plans.
✓ Accompaniment during external audits (customers, certifications, health authorities), as well as internal audits.
✓ Generation of reports, tracking of findings, and action plans.
✓ Control of attendance records and evaluation of training effectiveness.
✓ Support in risk management.
✓ CAPA.
✓ KPI management.
✓ Promote a culture of Good Documentation Practices within the organization.
✓ Assist in implementing quality process improvements.
✓ Support in administrative activities of the department.
COMPETENCIES
✓ Organization.
✓ Effective communication.
✓ Attention to detail.
✓ Proactivity.
✓ Responsible handling of sensitive and confidential information.
✓ Teamwork.
EDUCATION
✓ Completed bachelor’s degree in Pharmacy and Biochemistry (Q.F.B.), Industrial Pharmacy (Q.F.I.), Chemistry (I.Q.), or a related field in the Pharmaceutical Sector or Management Systems (preferably certified).
✓ Knowledge of ISO 9001:2015 and current NOM-059-SSA1.
✓ Intermediate English (desirable).
✓ Good Storage, Distribution, and Documentation Practices.
✓ Minimum 2 years’ experience in the pharmaceutical sector (desirable):
o Implementation of Management Systems.
o Risk management.
o Use of analytical tools.
o Good Documentation, Storage, and Distribution Practices.
o Basic knowledge of health regulation.
Employment type: Full-time
Salary: Starting from $20,000.00 per month
Workplace: On-site employment