QUALITY, HEALTH AND SAFE ANALYST - COLOMBIA

Quality Assurance Responsibilities:
• Support the internal QA system ensuring adherence to Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and local regulatory requirements (Medical Device Establishment License Colombia/CCAA)
• Collect and submit quality complaints through the complaint management system (MetricStream).
• Arrange the return of quality complaint samples to the manufacturing plant for investigation when necessary
• Track status of complaint investigation reports. Translate reports to Spanish and submit to clients.
• Responsible for the Document Control and Training systems at the local level and at the distribution center as applicable. Ensure compliance with Document Control and Training corporate programs and policies.
• Assist in document creation and review, including Standard Operating Procedures, protocols, and reports.
• Manage the Corrective Action/Preventive Action (CAPA) system for the local subsidiary using problem solving tools. Ensure compliance with the corporate CAPA program.
• Responsible for providing support with the supplier management program
• Assist in the tracking and monitoring of department metrics (KPI)
• Responsible for the procurement, approval, disposal and custody of printed material at the distribution center
• Report and manage non-conformities and non-conforming product reported at the distribution center during arrival of products, storage, supplemental labeling and shipping. Approve final disposal of non-conforming product. Perform lot assignment status and lot reclassifications on the ERP system.
• Approve and sign production batch records

Health & Safety Responsibilities
• Support the initial set-up of the Health & Safety Program in compliance with the local regulation (Decree 1443 of 2014 - Sistema de Gestión de la Seguridad y Salud en el Trabajo SG-SST).
• Assist in the preparation of the company´s Health & Safety Policy and establish annual goals and objectives
• Prepare the annual Health & Safety Plan
• Conduct identification and management of risks and hazards.
• Implement risk minimization measures and effectiveness assessment
• Set up metrics to assess performance of the Health & Safety system
• Prepare and perform the annual training program on Health & Safety
• Perform safety event / occurrence classification reviews
• Provide safety event / occurrence trend analysis identifying problem areas so resources can be deployed to improve performance

Required Skills & Background
• At least two years of experience in a pharmaceutical environment in areas of manufacturing, quality control lab or quality assurance.
• Desired knowledge of Health & Safety local regulations and implementation of Health & Safety systems
• University degree in Pharmaceutical Chemistry with
• English proficiency: The candidate should be able to read and understand technical documentation, draft basic correspondence.