QA Assistant: GMP Document Control & Records

Prinses Máxima Centrum voor kinderoncologie; Utrecht; On-site; EUR 42,000 - 48,000; Full time

Benefits offered by this job

Holiday allowance

End-of-year bonus

36-hour week

Job summary

The Princess Máxima Center for Pediatric Oncology in Utrecht is seeking a QA Assistant to support the Cell and Gene Unit (CGU) in a GMP environment. You will manage controlled documents, material disposition, and QA records to help ensure patient safety and compliance.

This full-time role (36 hours per week) offers a salary based on FWG 45, including 8.33% holiday allowance and 8.33% end-of-year bonus under the CAO ziekenhuizen.

Qualifications

• MBO-4 or HBO qualification in life sciences, pharmaceutical or laboratory technology, quality or administration, or comparable level gained through experience.
• Practical experience in document control, quality administration, materials or warehouse operations in GMP/GxP environments; ATMP experience is a plus.
• Basic knowledge of GMP, Good Documentation Practice and data integrity with strong attention to detail.
• Experience with EQMS, document management systems and Microsoft Office is an advantage.
• Good English level is required; Dutch is an asset.

Responsibilities

• Maintaining controlled SOPs, work instructions, forms, templates and logbooks with version control and archiving.
• Formatting and routing documents through review workflows and maintaining controlled registers.
• Preparing material disposition packages for GMP materials and verifying statuses and expiry dates.
• Checking supplier status, certificates and temperature records and escalating discrepancies.
• Maintaining quarantine, released, rejected and expired statuses and coordinating with warehouse and manufacturing.
• Performing completeness checks of production, QC and material records before QA review.
• Supporting deviations, CAPAs, changes, risk assessments, training records and quality trackers.

Skills

Attention to detail

English proficiency

Education

MBO-4 or HBO qualification in life sciences or related field

Tools

EQMS

Microsoft Office

Job description

The Princess Máxima Center for Pediatric Oncology in Utrecht is seeking a QA Assistant to support the Cell and Gene Unit (CGU) in a GMP environment. You will manage controlled documents, material disposition, and QA records to help ensure patient safety and compliance.

This full-time role (36 hours per week) offers a salary based on FWG 45, including 8.33% holiday allowance and 8.33% end-of-year bonus under the CAO ziekenhuizen.