SCIENTIFIC TECHNICAL RESPONSIBLE OFFICER

Description

Job Summary: The Technical Responsible Officer (TRO) will ensure compliance of storage, distribution, and manufacturing activities for health products with sanitary and regulatory standards. Key Highlights: 1. Act as the Technical Responsible Officer before regulatory authorities 2. Ensure operational compliance with Good Practices 3. Stay updated on applicable legislation and regulations **Description and Responsibilities:** **Working Hours:** 08:00 AM to 05:00 PM, 40 hours per week **Level:** Supervision/Coordination **Employment Type:** Permanent – CLT The Technical Responsible Officer (TRO) is responsible for ensuring that storage, distribution, and manufacturing activities for health products comply with applicable sanitary, regulatory, and quality standards. Acts as the technical representative before regulatory authorities, ensuring product integrity, traceability, and adherence to Good Practices. * Act as the Technical Responsible Officer before regulatory authorities, ensuring compliance with applicable legal and sanitary requirements. * Ensure operational compliance with Good Storage, Distribution, and Manufacturing Practices for Health Products. * Ensure appropriate storage conditions (temperature, humidity, organization, segregation, and product expiry), and manage and monitor deviations and non-conformities when/where necessary. * Supervise processes including receipt, inspection, storage, picking, and dispatch of products. * Ensure product traceability, including batch control, expiry dates, and movement history. * Develop, review, and maintain up-to-date Standard Operating Procedures (SOPs), manuals, and mandatory records. * Participate in internal and external audits, including sanitary inspections and customer audits. * Ensure company registration and licensing with competent authorities (sanitary licenses, authorizations, and applicable registrations). * Train and qualify staff on Good Practices, quality, and regulatory requirements, and monitor the manufacturing process. * Evaluate suppliers and ensure their compliance with regulatory and quality requirements. * Stay\-updated on legislation and regulations applicable to health products **Requirements:** Knowledge of Good Storage and Distribution Practices (GSDP), and preferably Good Manufacturing Practices (GMP) \- Advanced Knowledge or experience with ANVISA and local sanitary surveillance regulatory requirements \- Advanced Experience in process management, production flow, and traceability \- Intermediate Microsoft Office Suite (advanced Excel proficiency) \- Intermediate Microsoft Office Suite \- Intermediate Knowledge of quality/regulatory areas within the health sector \- Intermediate Knowledge of quality control, traceability, and non-conformance management \- Advanced **Benefits:** Medical assistance, Dental assistance, Education allowance, Internal benefits, On-site meals, Life insurance, Transportation allowance