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 escalate potential compliance issues
- Contribute to continuous improvement of controlled issuance processes
- Provide guidance and training to colleagues on documentation practices
Profiel
- 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 €4.700,- bruto per month, excluding shift allowance
- 40 hours fulltime with shifts, including periodic weekend shifts
- Region: Amsterdam
Vacancy number: 26925
