Compliance Support Pharma Job at Amaris Consulting (Braine-L'alleud)

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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Compliance Support Pharma

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