Job description
Mission Overview
Amaris is looking for a QA Specialist to support a leading pharmaceutical client in managing quality oversight of Contract Manufacturing Organizations (CMOs) within the External Manufacturing – Drug Product (EM Q DP) team. This role ensures product quality, regulatory compliance, and efficient collaboration across QA, IT, and operational departments in a global matrix environment.
You will play a key role in batch release, deviation/CAPA management, change control, and market complaint review, ensuring end-to-end quality accountability for outsourced manufacturing activities.
Key Responsibilities
* Ensure end-to-end quality accountability for CMOs, including oversight of:
o Deviation investigations
o CAPA implementation and closure
o Change control assessments and approvals
* Support product batch release processes in compliance with cGMP and regulatory requirements.
* Review and approve market complaints, ensuring timely and compliant evaluation.
* Collaborate with QA, IT, Regulatory, and Supply Chain teams within a complex, international matrix.
* Contribute to audits, regulatory inspections, and continuous improvement initiatives.
* Apply a pragmatic, problem-solving approach to quality challenges, balancing risk and operational needs.
Profile & Qualifications
* University degree in a scientific field: Bioengineering, Biology, Biotechnology, Pharmacology, Chemistry, or equivalent.
* 4–6 years of experience in a cGMP-regulated environment (pharma, biotech, or healthcare).
* Solid understanding of GMP, regulatory requirements, and quality systems in manufacturing.
* Strong technical writing skills – experience drafting and reviewing quality documentation.
* Good knowledge of SAP and Veeva is mandatory (or similar QMS/document management systems) is a strong asset.
* Analytical mindset with a global, pragmatic approach to problem solving.
* Proven ability to influence, network, and collaborate across functions and cultures.
* Fluency in French and English is mandatory
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.