Cell Therapy QA Specialist: Audits, CAPA & QMS Lead

AstraZeneca plc; Amsterdam; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

13th-month salary

27 vacation days

Pension plan

Internal training & development

Wellness budget & flexible benefits

Job summary

AstraZeneca plc in Amsterdam is seeking a Quality Assurance Specialist for Cell Therapy on a 12-month contract. The role blends hands-on QA with hosting audits and health authority inspections, focusing on batch documentation and QMS.

You will work with QP’s and QA colleagues to ensure compliant records, support CAPA closeouts, and help improve processes as our Cell Therapy operations grow. Hybrid model with three days on-site.

Qualifications

• Bachelor’s or master’s degree required.
• Experience hosting audits and Health authority inspections.
• Experience coordinating audits, compiling responses and CAPAs.
• Experience conducting self-inspections.
• Minimum 2 years QA in GMP manufacturing.
• Minimum 2 years writing and reviewing QA documentation (SOPs, procedures).
• 2+ years in deviations, CAPAs and change controls.
• Experience reviewing batch documentation and QA records.
• Strong GMP, QMS knowledge; apply GMP per US/EU/ROW.
• Experience with electronic QMS; Veeva preferred.
• English proficiency; Dutch a plus.

Responsibilities

• Support day-to-day Quality operations focusing on batch documentation.
• Contribute to QMS activities, training and meetings.
• Lead audits, inspections, and follow-up actions.
• Review batch docs for disposition and QP certification.
• Identify missing documentation and coordinate actions.
• Write, review and update SOPs, procedures and Quality docs.
• Review equipment/facility docs as we build the Cell Therapy Import Hub.
• Use digital/AI tools to improve Quality documentation.

Education

Bachelor’s or Master’s degree

Job description

AstraZeneca plc in Amsterdam is seeking a Quality Assurance Specialist for Cell Therapy on a 12-month contract. The role blends hands-on QA with hosting audits and health authority inspections, focusing on batch documentation and QMS.

You will work with QP’s and QA colleagues to ensure compliant records, support CAPA closeouts, and help improve processes as our Cell Therapy operations grow. Hybrid model with three days on-site.