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Quality Audit Specialist
Negotiable Salary
Indeed
Full-time
Onsite
No experience limit
No degree limit
R. Lazara Siqueira, 4 - Jardim Itapevi, Itapevi - SP, 06653-120, Brazil
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Description

Description: We are seeking professionals who meet the following requirements: * Completed undergraduate degree. * Experience in the field of quality audit. * Knowledge of national and international health regulations (ANVISA, FDA, EMA, WHO, INVIMA, DIGEMID, COFEPRIS). * Compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable legislation for the pharmaceutical industry. * Knowledge of quality tools. * Experience in supplier management and due diligence in acquisition and new product processes. * Knowledge of pharmaceutical processes and unit operations. * Experience in preparing for and supporting regulatory inspections. * Proficiency in quality management systems. * Languages: Advanced English is mandatory; advanced Spanish is desirable. * AVAILABILITY FOR INTERNATIONAL TRAVEL. Check the main day-to-day activities for this position: * Plan and conduct internal, external, and supplier audits using checklists, regulatory standards, and global policies, ensuring compliance with Good Manufacturing Practices, Good Laboratory Practices, and quality standards. * Develop and review policies based on regulatory standards and corporate guidelines, ensuring alignment of practices between Eurofarma and its subsidiaries. * Support and accompany regulatory inspections at all stages, using quality management tools and technical reports, ensuring alignment with health authorities and maintenance of corporate reputation. * Conduct quality due diligence in company and product acquisition processes, licensing, and new product development, through evaluation of technical documentation and pre-audits, providing strategic information to support senior management decision-making. * Monitor and evaluate corrective and preventive action (CAPA) plans, based on audit reports and tracking tools, ensuring effectiveness of implemented actions and mitigation of quality risks. * Interact and align with internal departments, subsidiaries, and suppliers through meetings, training sessions, and continuous follow-up, promoting a quality culture and adherence to global policies. * Prepare and distribute audit, inspection, and critical analysis reports using corporate systems and management tools, providing visibility and support for managerial and strategic decision-making. 2512210202551876301

Source:  indeed View original post
João Silva
Indeed · HR

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