Quality Operations Coordinator

Overview

In this role you support quality oversight in manufacturing, ensuring GxP compliance and robust collaboration between Quality and Production. You review batch records, manage events, and drive improvements through CAPA to strengthen GMP adherence. You will help maintain GMP documentation and contribute to development projects that deepen production knowledge. Join a quality-focused team that enables safe, compliant production and reliable product quality.

Responsabilità

• Review and ensure the execution of quality batch record review in compliance with SOPs and regulations
• Open and manage events identified during batch record review and/or reported by production operators
• Review production procedures and master batch record
• Identify improvement opportunities and implement CAPA to increase GMP compliance in production areas
• Actively collaborate with Production to identify and resolve compliance gaps, both documentation-related and on the shop floor
• Lead/execute development projects aimed at deepening knowledge of production activities
• Ensure GMP documentation management, including archiving, data collection, and document destruction
• Prepare equipment cleaning samples
• Verify the compliance of plasma receipt requirements

Requisiti fondamentali

• Degree in scientific discipline or demonstrated/approved knowledge of manufacturing processes
• Good command of English
• Excellent knowledge of the manufacturing process and quality principles
• Good knowledge of cGMP
• Good ability to work independently
• Good communication and negotiation skills
• Problem-solving attitude
• Good teamwork skills
• Good communication skills
• Problem-solving attitude
• Leadership skills
• GxP/cGMP knowledge
• CAPA management
• Documentation management

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