GMP Quality Assurance Specialist, ATMP & Cell Therapy

Evotec WD; Modena; On-site; EUR 45,000 - 65,000; Full time

Job summary

Evotec is seeking a GMP Quality Assurance professional for its cell therapy manufacturing site in Modena, Italy. The role focuses on ensuring ATMP manufacturing compliance, managing documentation, and driving improvements across the Cell Factory operations.

The ideal candidate has at least 3 years in QA, knowledge of GxP, and experience with sterile products and environmental monitoring. Proactive, team-focused individuals with strong organizational skills are encouraged to apply.

Qualifications

• Minimum 3 years of Quality Assurance experience.
• ATMP experience is a plus.
• Experience with sterile products is desirable.
• Experience in environmental monitoring and safety methods is preferred.
• Documentation management of GMP records is required.

Responsibilities

• Manage a comprehensive QA documentation system for Cell Factory operations.
• Collaborate in risk analyses to ensure product quality and compliance.
• Contribute to change management processes.
• Oversee deviations and CAPA activities and track closeout.
• Regularly inspect all departments for GMP compliance and readiness.
• Contribute to training plans for new and existing staff.
• Qualify external suppliers and monitor performance.
• Handle complaints and ensure timely resolution.
• Distribute production batch records and ensure accuracy.
• Execute Batch Record Review and ensure traceability.

Skills

GxP knowledge

Teamwork

Prioritization

Deadline driven

English (intermediate)

MS Office

Education

BS/MS in Biotechnology/Biology/Pharmacy

Job description

Evotec is seeking a GMP Quality Assurance professional for its cell therapy manufacturing site in Modena, Italy. The role focuses on ensuring ATMP manufacturing compliance, managing documentation, and driving improvements across the Cell Factory operations.

The ideal candidate has at least 3 years in QA, knowledge of GxP, and experience with sterile products and environmental monitoring. Proactive, team-focused individuals with strong organizational skills are encouraged to apply.