Quality Assurance Analyst (Mid-Level)
Posted 1hrs ago
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Job Description
Analista de Garantia da Qualidade aprimorando SGQ, BPF e conformidade regulatória na unidade de Linhares. Condução de CAPA, auditorias, documentos, riscos e melhoria contínua.
Responsibilities:
- Execute, maintain, and improve the Quality Management System (QMS) processes at the Linhares site
- Prepare, review, and approve SOPs, work instructions, forms, plans, reports, and other quality documents
- Manage document and record control, ensuring version control, distribution, traceability, retention, archiving, and periodic review
- Lead investigations into deviations and nonconformities using root-cause analysis tools
- Manage corrective and preventive actions (CAPA), monitoring plans, deadlines, evidence, and effectiveness
- Lead the Change Control process and coordinate impact assessments
- Participate in quality risk management
- Plan and monitor training related to Good Manufacturing Practices (GMP) and the QMS
- Plan, conduct, or participate in internal, supplier, and customer audits
- Prepare areas and documentation for health authority inspections and external audits
- Conduct and monitor the qualification and oversight of critical suppliers and service providers
- Monitor quality complaints and support investigations and actions
- Prepare and analyze QMS performance indicators, identifying trends, risks, and improvement opportunities
- Support validation and qualification programs from a Quality Assurance perspective
- Promote Good Documentation Practices and data integrity
- Provide guidance to Junior Analysts, Inspectors, and other departments on QMS and GMP requirements
- Work with Production, Quality Control, Logistics, Maintenance, Engineering, and other departments to resolve quality-related issues
- Propose and implement improvements and stay up to date with legislation and standards applicable to cosmetic manufacturing
Requirements:
- Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Production Engineering, Biomedical Sciences, or a related field
- Experience in Quality Assurance or Quality Management Systems, preferably in the cosmetics, pharmaceutical, medical device, food, or chemical industries
- Knowledge of Good Manufacturing Practices (GMP) applicable to the cosmetics industry
- Knowledge of Quality Management Systems and document and record control
- Knowledge of deviation management, nonconformities, CAPA, and Change Control
- Knowledge of investigation and root-cause analysis tools, such as the 5 Whys, Ishikawa diagrams, and risk analysis
- Knowledge of internal audits, supplier qualification, and action plan follow-up
- Knowledge of Good Documentation Practices and data integrity principles
- Knowledge of quality indicators and trend analysis
- Proficiency in Microsoft Office, especially Word, Excel, and PowerPoint
- Preferred: experience in the cosmetics, pharmaceutical, or food industry and in QMS implementation or development
- Preferred: knowledge of Brazilian regulations RDC No. 48/2013, ISO 22716, and other regulatory requirements applicable to the cosmetics sector
- Preferred: experience with regulatory, customer, and/or supplier audits
- Preferred: knowledge of validation, equipment qualification, cleaning validation, and process validation
- Preferred: experience with electronic quality management systems, ERP, or SAP
- Preferred: intermediate English proficiency
Benefits:
- Employment under Brazil’s CLT labor regime
- Remote work as indicated in the job posting header


















