Quality Pharmacist

Description

Job Summary: Responsible for the implementation, maintenance, and monitoring of the QMS, ensuring compliance with legislation and Good Transportation Practices (GTP), guaranteeing quality and safety. Key Highlights: 1. Lead the implementation and maintenance of the Quality Management System (QMS) 2. Manage deviations, non-conformities, and internal/external audits 3. Serve as a strategic interface between regulatory and operational departments Mission: Responsible for the implementation, maintenance, and monitoring of the Quality Management System (QMS), ensuring compliance with applicable legislation, regulatory standards, and Good Transportation Practices (GTP), thereby guaranteeing quality, safety, and integrity of processes and products. Responsibilities: * Implement, maintain, and monitor the Quality Management System (QMS), ensuring compliance with Good Transportation Practices (GTP). * Develop, review, and control quality documents, including SOPs, work instructions, manuals, forms, and records. * Manage deviations, non-conformities, complaints, NCs, and investigations, including conducting root cause analyses. * Develop, track, and verify the effectiveness of corrective action plans. * Conduct and support internal and external audits, as well as respond to sanitary inspections (ANVISA, local Health Surveillance, customers, and certification bodies). * Perform qualification and evaluation of suppliers, service providers, and critical third parties. * Execute change control, assessing regulatory and quality impacts. * Plan and conduct training and capacity-building sessions for employees on quality-related topics, good practices, and applicable legislation. * Monitor quality indicators (KPIs) and prepare management reports. * Support validation and qualification processes, including equipment, transportation routes, computerized systems, and facilities. * Ensure data traceability and integrity. * Serve as the interface between regulatory affairs, operations, logistics, and production departments, ensuring alignment, compliance, and technical guidance regarding necessary impacts and adjustments. Requirements: * Bachelor’s degree in Pharmacy; * Active Regional Council of Pharmacy (CRF) registration; * Prior experience in Quality and engagement with regulatory authorities. * Solid knowledge of transportation legislation; * Experience in team management and regulatory/quality projects. * Analytical, organized profile with strong communication and negotiation skills.