QA Documentation Specialist

Oxford Global Resources; Amsterdam; On-site; EUR 50,000 - 56,000; Full time

Benefits offered by this job

Long term position

Salary range €4,500 - €5,000 per month

40 hours fulltime with shifts

Job summary

Oxford Global Resources is seeking a Quality Operations Documentation Specialist in Amsterdam to safeguard GMP‑related documentation and support product release activities.

You will review, verify and improve documentation, ensuring compliance while collaborating with multiple internal teams and providing training on documentation practices.

Qualifications

• Bachelor's or master's degree with at least two years of experience in document management within a regulated environment.
• Solid understanding of GMP principles.
• Advanced proficiency in English, both written and spoken.
• Strong attention to detail and a structured working style.

Responsibilities

• Review and verify GMP-related documentation and batch records.
• Check and maintain controlled logbooks.
• Ensure QA documentation is complete, accurate, and compliant.
• Identify and address potential compliance issues.
• Contribute to continuous improvement of issuance processes.
• Provide guidance and training on documentation practices.

Skills

Attention to detail

Structured working style

Advanced English

Education

Bachelor's or Master's degree in a relevant field

Job description

Introduction

We are looking for a Quality Operations Documentation Specialist. This role is based in a highly regulated and innovative environment where advanced therapies are developed for patients with complex oncological conditions. Quality, compliance, and precision are essential elements of daily operations.

Job Description

As a Quality Operations Documentation Specialist, you play a key role in safeguarding the integrity of GMP-related documentation that supports manufacturing and product release activities. You are responsible for reviewing and managing quality documentation to ensure it is accurate, complete, and compliant with applicable guidelines. In addition, you contribute to the identification and investigation of documentation-related deviations and actively support initiatives aimed at improving documentation and issuance processes. The role involves close collaboration with multiple internal teams and clear communication regarding documentation procedures and requirements.

Responsibilities

• Review and verify batch records and label documentation in line with cGMP standards
• Check and maintain controlled logbooks
• Ensure QA documentation is complete, accurate, and compliant
• Identify and escape potential compliance issues
• Contribute to continuous improvement of controlled issuance processes
• Provide guidance and training to colleagues on documentation practices

Requirements

• Bachelor's or master's degree with minimal two years of experience in document management within a regulated environment
• Solid understanding of GMP principles
• Advanced proficiency in English, both written and spoken
• Strong attention to detail and structured working style

Benefits

• Long term position, start through Oxford
• Salary range €4.500 - €5.000 per month
• 40 hours fulltime with shifts, including periodic weekend shifts
• Region: Amsterdam

Vacancy number: 26925