Description
Job Summary:
Responsible for ensuring that processes and products meet safety, quality, and regulatory standards through analysis and support of continuous improvement.
Key Highlights:
1. Ensure safety, quality, and regulatory compliance standards
2. Conduct inspections and analyses to ensure product quality
3. Support continuous improvement initiatives and process development
Responsible for ensuring that processes and products comply with safety, quality, and regulatory requirements, guaranteeing safe, effective, and legally compliant delivery to the end consumer in accordance with both internal factory standards and applicable laws. Additionally, perform analyses to verify compliance and support continuous improvement initiatives.
Requirements:
* Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or related fields.
* Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
* Familiarity with ANVISA regulations, physicochemical analytical techniques, and quality tools.
* Knowledge of measurement and inspection instruments, such as balances, pH meters, viscometers, etc.
* Microsoft Office suite (Excel, Word, Power BI, PowerPoint).
Responsibilities:
* Verify and ensure compliance with applicable regulations and standards (e.g., ANVISA, ISO, RDC), while also ensuring adherence to safety and environmental standards within the production environment.
* Conduct inspections and analyses of raw materials, in-process products, and finished goods to ensure quality at all stages.
* Monitor and control production processes, ensuring compliance with established Quality standards.
* Track and investigate quality deviations, nonconformities, and detected anomalies, proposing corrective and preventive actions.
* Develop, implement, and review standard operating procedures (SOPs) and other Quality-related documents, ensuring standardization and compliance.
* Provide technical support to internal departments (Production, R&D, Customer Service), contributing to problem resolution and process improvement.
* Conduct training and capacity-building sessions on Good Manufacturing Practices (GMP) and Quality, promoting employee development.
* Conduct analyses to ensure batch traceability throughout the entire production chain.
* Monitor and analyze Quality indicators, preparing technical reports to support decision-making.
* Conduct and lead internal audits to ensure compliance with ANVISA regulations, certification body requirements, and customer specifications.
* Support the production team in implementing continuous improvements, optimizing processes and products.
* Analyze and validate physicochemical test results, ensuring data accuracy and reliability.
* Ensure proper identification and segregation of nonconforming products, preventing risks associated with use or distribution.
* Participate in the development and validation of new processes and products, contributing a Quality perspective.
* Collaborate in the control, maintenance, and calibration of measurement equipment, ensuring their reliability.