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Amaris Consulting Logo Amaris Consulting · Health and Beauty

Compliance Support Pharma

Belgium, Braine-L'alleud · Job Posted May 28, 2026
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Job Description

As a QA Specialist, Deviation Management, you will join the Compliance Support Production team (7 people with QA Ops / Manufacturing profiles) to ensure GMP compliance within a Fill & Finish injectables manufacturing environment. This role is a 100% replacement for a maternity leave and focuses strongly on end-to-end deviation management related to manufacturing activities. You will work in close collaboration with Production, QA and Microbiology teams and spend a significant part of your time in the production areas.

Job Responsibility

  • Perform impact assessments on product and process in case of deviations
  • Lead and execute investigations and root cause analyses
  • Prepare, write and maintain deviation documentation in compliance with internal procedures and GMP requirements
  • Ensure timely closure of deviations and contribute to the definition and follow-up of corrective and preventive actions (CAPA)
  • Be regularly present in production areas (Fill & Finish injectables)
  • Conduct on-the-floor investigations to collect facts and evidence
  • Perform Batch Record reviews, mainly in production zones, and ensure data integrity and compliance
  • Act as a key QA point of contact for production teams regarding deviations
  • Provide support during internal and external audits/inspections (e.g. health authorities, clients)
  • Prepare and organize deviation-related documentation for inspections
  • Support QA and Production teams in answering questions related to deviations (supporting role, not front-line facing inspectors)

Requirements

  • Master’s degree in biology, chemistry, biochemistry, engineering or related field OR Bachelor’s degree with strong, relevant experience
  • Minimum 2–3 years of experience in a GMP pharmaceutical environment
  • Experience in Fill & Finish / injectable manufacturing is highly preferred
  • Proven hands-on experience in deviation management (investigation, root cause analysis, documentation)
  • Strong knowledge of GMP and pharmaceutical manufacturing processes
  • Excellent writing skills (clear, structured, concise deviation reports)
  • Strong analytical and problem-solving mindset, structured and solution-oriented
  • Ability to be operational quickly and work independently on deviations (no junior profiles)
  • Mandatory and regular presence in production areas
  • Full compliance with GMP requirements: gowning procedures, hygiene rules, no jewelry/piercings, respect of classified zones
  • French: Fluent (mandatory)
  • English: basic/limited, not a blocking point

Nice to have

  • Experience in QA Operations / Manufacturing and/or QC / Microbiology with exposure to deviations
  • Knowledge of GMP IT systems, such as SAP
  • LIMS
  • Deviation management tools
  • OP Center (electronic batch records)

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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