QA Documentation Specialist

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

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