Manager I
2 semanas atrás
**Date**:Jun 3, 2025
**Location**: Cotia, São Paulo, Brasil, Brazil
**Company**:ACG
- Group Company
- ACG Nova Nordeplast (NNP)
- Primary Responsibilities- Ensure quality assurance objectives are met, managing deviations, customer complaints, and leading CAPA processes.- Develop, implement, and maintain an integrated Quality Management System (QMS) in compliance with GMP and applicable regulatory standards.- Monitor industry and regulatory trends (pharmaceutical, printing, and thermo-packaging) to ensure ongoing compliance.- Attend and lead internal and external audits, ensuring readiness and adherence to client and agency requirements.- Conduct risk assessments, define critical control points, and implement monitoring, verification, and preventive measures.- Validate processes by establishing product specifications, executing operational and performance qualifications, and managing related documentation.- Develop and update quality assurance procedures, SOPs, and product quality records.- Manage and support the QA laboratory and testing methodologies aligned with the industry and company technologies.- Prepare and analyze quality data, trend reports, and documentation related to failed processes, stability studies, and re-validations.- Review and approve customer purchase orders, contracts, and change requests to ensure integration of quality requirements.- Implement and track quality KPIs, supporting continuous improvement and annual quality objectives.- Lead training initiatives to strengthen team knowledge and support compliance culture.- Represent the quality area in meetings with ACG Directors and Clients, including preparation of technical presentations.- Coordinate and execute Quality Walks in the plant.- Support NNP management in regulatory and quality-related matters, including document traceability and system updates.
- Key Interfaces
- Internal:
- All functions
- External:
- Clients
- Government
- Entities related to Regulatory topics
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