Quality Analyst

Description

Job Summary: We are seeking a Quality Analyst with focus on regulatory compliance, continuous improvement, and product safety to maintain and improve the QMS. Key Highlights: 1. Key role in maintaining and improving the Quality Management System 2. Focus on regulatory compliance and continuous improvement 3. Regulated environment governed by ANVISA We are looking for a **Quality Analyst** with strong attention to detail, a sense of responsibility, and the willingness to contribute to process excellence. This professional will be a **key player** in maintaining and improving the Quality Management System (QMS), focusing on **regulatory compliance, continuous improvement**, and **product safety**. If you have a **solid technical education, analytical capability, organizational skills, and interest in working in an ANVISA-regulated environment**, this position is for you. **Main Responsibilities:** * Assist in maintaining and improving the Quality Management System (QMS), ensuring compliance with RDC 665/2022 requirements and Good Manufacturing Practices (GMP); * Participate in drafting, reviewing, and controlling quality documents such as Standard Operating Procedures (SOPs), work instructions, records, and forms; * Support internal audit execution, contributing to corrective action plans and tracking resolution progress; * Conduct inspections and verifications of production processes to ensure product conformity with technical specifications and regulatory requirements; * Monitor quality performance indicators (KPIs), analyze data, and propose continuous improvement actions; * Assist in investigating non-conformities, technical complaints, and deviations using methodologies such as 5 Whys, Ishikawa, or similar; * Support implementation of quality programs such as 5S, continuous improvement, and change control; * Contribute to onboarding and technical training on quality-related topics and sanitary regulations. **Requirements:** * Currently enrolled in or holding a bachelor’s degree in Engineering, Pharmacy, Biomedicine, Quality Management, or related fields; * Basic knowledge of quality tools (PDCA, 5 Whys, Ishikawa Diagram, etc.); * Familiarity with ANVISA legislation and applicable ISO standards is desirable; * Proficiency in Microsoft Office suite; * Strong communication and organizational skills. **Preferred Qualifications:** * Prior experience in regulated sectors (healthcare products industry, pharmaceutical industry, or hospital settings); * Training courses in quality, GMP, or internal auditing. **WORK SCHEDULE:** Monday to Thursday: 7:00 AM to 12:00 PM and 1:00 PM to 5:00 PM Friday: 7:00 AM to 12:00 PM and 1:00 PM to 4:00 PM Benefits: – Meal allowance; – Health insurance; – Dental insurance; – Pharmacy discount program; – Birthday day off; – Weekly breakfast; – Fruit day.