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Quality Engineer
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
BR-373, 097 - Centro, Limeira - SP, 13480-013, Brazil
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Description

Description: Requirements: * Bachelor's degree in Chemical Engineering. * Knowledge of unit operations, fermenters and/or chemical reactors, separation and purification of pharmaceutical or food products is required; * Ability to analyze experimental data, identify trends, and propose solutions; familiarity with process/production equipment in the processing/food/chemical industry; * Knowledge of GMP, FSSC 22000, ANVISA RDC 654/22 GMP for API, ANVISA Guide 33 for Computerized System Validation, Sindusfarma Guide 31 for Cloud Supplier Validation, and GAMP 5 is required; * Solid knowledge of Office suite (Power BI desirable); * Advanced/Fluent English. * Will work in partnership with the Quality Assurance team and related areas to ensure that production processes and final products comply with quality and safety regulations applicable to the pharmaceutical and food industries, such as cGMP and FSSC. The professional will develop and monitor quality systems and implement continuous improvements to meet customer expectations and regulatory standards. This role requires technical skills for critical process analysis, as well as experience in manufacturing process routines where unit operations are implemented for physical and chemical processes. * Ensure Product Compliance and Quality, addressing validation, qualification, and CSV (Computer System Validation), being part of the team responsible for equipment qualification and process validation to ensure they meet operational parameters and quality specifications. * Risk Analysis and Preventive Controls: Perform risk analysis of the manufacturing process and propose appropriate preventive controls using methodologies such as STPD (See, Think, Plan and Do), FMEA (Failure Modes and Effects Analysis), and HACCP (Hazard Analysis and Critical Control Points). * Troubleshooting Analysis: Conduct troubleshooting analyses to resolve technical and operational issues impacting product quality or process efficiency. * Introduce gamification elements into continuous improvement programs to encourage team engagement. * Take initiatives in Digital Transformation for process and data management, leveraging cutting-edge technologies. Be part of the team implementing real-time monitoring systems for data collection, enabling continuous analysis and rapid identification of deviations. * Be part of the FSMS (Food Safety Management System) team in implementing Food Safety, Food Defense programs, and ensuring compliance with Food Fraud prevention standards. * Knowledge and experience in Good Manufacturing Practices and Data Integrity (Data Integrity \- ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)) in the pharmaceutical and/or food industries. * Perform follow-up/feedback according to action plans proposed for ongoing implementation projects; * Be part of the team to develop and lead training programs on quality tools and continuous improvement, including team capability building for data analysis and digital process monitoring, to ensure a culture of improvement and innovation. * Collaborate with multidisciplinary teams, serving as a liaison between your area in Quality Assurance and technical areas such as Quality Control, Manufacturing Process, Engineering\&Maintenance, providing technical support when necessary. * Will be eligible, together with the Quality Assurance team, to analyze and respond to customer complaints related to product quality, conducting on-site customer inspections when needed, and proposing process improvements to prevent recurring issues. * Continuously update procedures and protocols according to regulatory changes. * Strong communication and problem-solving skills across different functional areas. 2509060202421048439

Source:  indeed View original post
João Silva
Indeed · HR

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