GMP QA Specialist – ATMP Cell Therapy

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

Job summary

Evotec SE in Modena, Italy is seeking a GMP Quality Assurance professional, possibly experienced in aseptic manufacturing, to ensure GMP compliance across Cell Factory operations and related activities.

You will manage documentation, support risk analysis, deviations, CAPA, and supplier qualification, collaborating with cross-functional teams to guarantee quality and regulatory readiness for ATMP manufacturing.

Qualifications

• 3+ years of experience in Quality Assurance mandatory.
• Experience with ATMPs is a plus.
• Experience with sterile products preferred.
• Experience in environmental monitoring, safety methods and media-fill activities.
• GxP guidelines knowledge is required.

Responsibilities

• Manage a comprehensive documentation system for Cell Factory operations.
• Collaborate in risk analysis and change management system.
• Manage deviations and CAPA (corrective/preventive actions).
• Regularly inspect departments and assess GMP compliance status.
• Support training plans for new and existing staff.
• Qualify external suppliers and handle complaints.
• Distribute production batch records and execute Batch Record Review.
• Document management across QA activities.

Skills

GxP guidelines knowledge

Team player

Prioritization & organization

Deadline-driven

English (intermediate)

MS Office proficiency

Education

BS or MS in Scientific field (Biotechnology/ Biology/ Pharmacy)

Tools

Microsoft Office

Job description

Evotec SE in Modena, Italy is seeking a GMP Quality Assurance professional, possibly experienced in aseptic manufacturing, to ensure GMP compliance across Cell Factory operations and related activities.

You will manage documentation, support risk analysis, deviations, CAPA, and supplier qualification, collaborating with cross-functional teams to guarantee quality and regulatory readiness for ATMP manufacturing.