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GMP Compliance Medior Pharmaceuticals

Belgium, Wavre · Job Posted February 14, 2026

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Job Description

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.

Job Responsibility

  • Ensure end-to-end quality accountability for CMOs, including oversight of: Deviation investigations
  • CAPA implementation and closure
  • 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

Requirements

  • 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

Nice to have

Good knowledge of SAP and Veeva is mandatory (or similar QMS/document management systems) is a strong asset

What we offer

  • 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

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