GMP Quality Assurance Specialist ATMP Cell Therapy

Evotec SE; Emilia-Romagna; On-site; EUR 55,000 - 75,000; Full time

Job summary

Evotec SE in Modena, Italy, is seeking a GMP Quality Assurance professional, experienced in aseptic manufacturing, to join the Cell and Gene Therapy team and ensure ATMP manufacturing activities meet company and intercompany standards.

You will help manage documentation, support risk analyses, change control, deviations/ CAPAs, training plans, supplier qualification, batch records, and batch record reviews in a compliant GMP environment.

Qualifications

• 3+ years of QA experience mandatory.
• ATMP experience is a plus.
• Experience with sterile products.
• Environmental monitoring, safety methods and mediafill experience.
• Knowledge of current GxP guidelines.
• English intermediate (written and spoken).

Responsibilities

• Manage a comprehensive documentation system for all Cell Factory operations.
• Collaborate in risk analyses.
• Collaborate in change management system.
• Manage deviations and corrective/preventive actions.
• Regularly inspect all departments for GMP compliance.
• Support the development of training plans for staff.
• Qualify external suppliers.
• Handle complaints.
• Distribute production batch records.
• Execute the Batch Record Review.
• Document management.

Skills

GxP knowledge

Team player

Organizational skills

Deadline oriented

English (intermediate)

Education

BS or MS in Biotechnology/Biology/Pharmacy

Tools

MS Office

Job description

Evotec SE in Modena, Italy, is seeking a GMP Quality Assurance professional, experienced in aseptic manufacturing, to join the Cell and Gene Therapy team and ensure ATMP manufacturing activities meet company and intercompany standards.

You will help manage documentation, support risk analyses, change control, deviations/ CAPAs, training plans, supplier qualification, batch records, and batch record reviews in a compliant GMP environment.