Cell Therapy QA Specialist — Hybrid Amsterdam

AstraZeneca GmbH; Amsterdam; Hybrid; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Bonus scheme

13th month salary

Pension plan

Share purchase plan

Flexible benefits

Job summary

AstraZeneca Amsterdam is expanding its Cell Therapy quality team. The Quality Assurance Specialist mixes hands-on QA with Global QMS activities, collaborating with QPs and Quality colleagues to keep documentation complete, correct and compliant.

Role involves 70% daily quality ops and 30% process improvements, audits, and training, with a strong emphasis on batch documentation, CAPAs and Change Controls in a growing cell therapy facility.

Qualifications

• Bachelor’s or Master’s degree.
• At least 2 years of hands-on Quality Assurance in GMP manufacturing.
• At least 2 years writing/reviewing Quality documentation (SOPs, procedures).
• At least 2 years with deviations, CAPAs, change controls.
• Experience reviewing batch documentation and Quality records.
• Strong GMP knowledge and Quality Systems.

Responsibilities

• Review batch documentation for disposition and QP certification.
• Identify missing/incomplete docs and coordinate actions.
• Write, review, and update SOPs and Quality docs.
• Review Quality/mfg records to identify gaps, risks and follow-ups.
• Investigate deviations and coordinate CAPAs.
• Review and approve Change Controls.
• Facilitate Change Control Review Board meetings.
• Prepare Quality data for management reviews.
• Train colleagues on GMP and QMS processes.
• Prepare for audits and inspections.

Skills

Quality Assurance

Documentation

GMP knowledge

QMS

Veeva

English proficiency

Education

Bachelor’s or Master’s degree

Tools

Veeva Systems

Electronic QMS

Job description

AstraZeneca Amsterdam is expanding its Cell Therapy quality team. The Quality Assurance Specialist mixes hands-on QA with Global QMS activities, collaborating with QPs and Quality colleagues to keep documentation complete, correct and compliant.

Role involves 70% daily quality ops and 30% process improvements, audits, and training, with a strong emphasis on batch documentation, CAPAs and Change Controls in a growing cell therapy facility.