Quality Operations Lead – GMP & Batch Records

ITA - 8290 Takeda Manufacturing Italia S.P.A.; Rieti; On-site; EUR 31,000 - 43,000; Full time

Job summary

Takeda Manufacturing Italia S.P.A. in Italy (Rieti) is seeking a Quality Oversight professional to verify batch records, ensure GMP compliance, and collaborate with Production to close gaps. The role emphasizes data integrity and leadership in quality processes across the production site.

The candidate should hold a scientific degree, have strong English skills, and demonstrate knowledge of GMP and manufacturing principles. The position is full-time and based on site in Rieti.

Qualifications

• Degree in scientific discipline or equivalent with knowledge of pharmaceutical regulations.
• Good command of English (written and spoken).
• Strong knowledge of manufacturing processes, quality principles, and GMP/CgMP requirements.

Responsibilities

• Review and ensure execution of quality batch record review per SOPs and regulations.
• Open and manage events identified during batch record review or reported by production operators.
• Review production procedures and master batch records.
• Identify improvement opportunities and implement CAPAs to improve GMP compliance.
• Collaborate with Production to identify and resolve compliance gaps and ensure traceability of GMP documentation.
• Lead or support development projects to deepen knowledge of production activities.
• Ensure GMP documentation management, including archiving, data collection, and destruction of documents.
• Prepare equipment cleaning samples and verify plasma receipt compliance.

Skills

GxP knowledge

English skills

Quality leadership

Problem solving

Data integrity

Education

Scientific degree

Job description

Takeda Manufacturing Italia S.P.A. in Italy (Rieti) is seeking a Quality Oversight professional to verify batch records, ensure GMP compliance, and collaborate with Production to close gaps. The role emphasizes data integrity and leadership in quality processes across the production site.

The candidate should hold a scientific degree, have strong English skills, and demonstrate knowledge of GMP and manufacturing principles. The position is full-time and based on site in Rieti.