Job description
About the Role
We are seeking a Quality Management System Documentation Specialist to join our growing Quality team in the pharmaceutical sector. This key role ensures the accuracy, compliance, and integrity of all Quality Management System (QMS) documentation. The ideal candidate will be highly organized, detail-oriented, and experienced in managing documentation within a regulated pharmaceutical environment.
This position is perfect for a proactive professional with a strong personality and solid experience in quality systems from a documentary perspective.
Key Responsibilities
* Own and manage QMS documentation, ensuring compliance with GxP, GMP, ISO 13485, and other regulatory standards.
* Maintain and control the SOP (Standard Operating Procedures) library, including document lifecycle management: drafting, review, approval, distribution, revision, and obsolescence.
* Manage the document database – ensure data integrity, version control, access rights, and audit readiness in electronic and paper-based systems.
* Serve as the primary point of contact for document control activities across Quality, Manufacturing, R&D, and Regulatory Affairs.
* Support internal and external audits by providing timely and accurate documentation.
* Drive continuous improvement initiatives for document workflows, usability, and digitalization.
* Ensure all documentation practices align with corporate policies and international regulatory requirements.
Qualifications & Experience
* Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
* Minimum of 3 years of experience in document control or quality systems within the pharmaceutical, biotech, or medical device industry.
* Proven experience with electronic document management systems (EDMS) such as SharePoint, Veeva Vault, MasterControl, Qualio, or similar.
* Solid understanding of GMP, FDA, EMA, and ISO standards as they relate to documentation.
* Strong organizational skills, attention to detail, and ability to work independently in a fast-paced environment.
* Excellent communication skills and ability to collaborate across departments.
* Fluent in English; French are a plus.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.