09 ott - Lombardia
Takeda
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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