Responsible Technical Pharmacist

Description

Job Summary: The RT ensures the integrity, quality, and safety of distributed medicines, guaranteeing strict compliance with sanitary legislation. Key Highlights: 1. Regulatory and Document Management: AFE, AE, BPDA, SOPs, and licenses. 2. Quality Control and Operations: Suppliers, receiving, cold chain. 3. Pharmacovigilance and Reverse Logistics: Recalls, returns, quality deviations. Role Summary: Ensure the integrity, quality, and safety of distributed medicines, ensuring all company operations strictly comply with current sanitary legislation. The RT serves as the liaison between the distributor, regulatory bodies (CFF/CRF, Sanitary Surveillance, and ANVISA), and the end customer. \- Duties and Responsibilities \- The competencies of an RT in a distribution company are broad and can be divided into pillars: 1\. Regulatory and Document ManagementMaintain and renew the AFE (Company Operating Authorization) and AE (Special Authorization), if applicable to Portaria 344/98 management.Manage the Good Distribution and Storage Practices Manual (BPDA).Develop, review, and train staff on SOPs (Standard Operating Procedures).Monitor compliance certificates issued by the CRF and sanitary licenses. 2\. Quality Control and OperationsSupplier and Customer Qualification: Ensure the company purchases from and sells only to duly licensed establishments.Receiving and Inspection: Supervise product intake, verifying integrity, batch number, expiry date, and invoice.Cold Chain: Rigorously monitor temperature and humidity (especially for thermolabile products), ensuring instrument calibration.Internal Audits: Conduct periodic internal audits to identify process failures. 3\. Pharmacovigilance and Reverse LogisticsManage the product recall system jointly with manufacturers and sanitary authorities.Handle returns and ensure segregation of damaged, expired, or suspected counterfeit products.Notify quality deviations to product registration holders. 4\. Controlled Substances Management (if applicable)Record and manage inventory in the SNGPC (National Controlled Products Management System).Secure key storage and control access to controlled medication stock. Compensation: R$5\.000,00 \- R$6\.000,00 per month Benefits: * Medical assistance * Meal allowance * Transportation allowance Work Location: On-site