Responsible Pharmacist (Technical Manager)

Description

Job Summary: The Technical Manager ensures the integrity, quality, and safety of distributed medicines, guaranteeing strict compliance with sanitary legislation. Key Highlights: 1. Regulatory and Documentation Management of Medicines 2. Quality Control and Operations of Pharmaceutical Products 3. Pharmacovigilance and Reverse Logistics 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. \- Responsibilities and Duties \- The RT's competencies in a distribution company are broad and can be divided into pillars: 1\. Regulatory and Documentation ManagementMaintain and renew the AFE (Company Operating Authorization) and AE (Special Authorization), if applicable under Ordinance No. 344/98.Manage the Good Distribution and Storage Practices (GDSP) Manual.Develop, review, and train staff on SOPs (Standard Operating Procedures).Monitor compliance certificates issued by 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 in coordination 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 control inventory in the SNGPC (National System for Managing Controlled Products).Secure key storage and access control to controlled medicine stock. Compensation: R$5,000.00 \- R$6,000.00 per month Benefits: * Medical assistance * Meal allowance * Transportation allowance Workplace: On-site