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