Job description
Mission Context
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.
Key Responsibilities
1. Deviation Management (End-to-End)
* 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).
2. On-the-Floor Investigations (Gemba)
* 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.
3. Audit & Inspection Support
* 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).
4. Daily Activities
A typical day is a hybrid between office work and shop floor presence:
* Time split between analysis & deviation writing, field investigations, and coordination with Production, QA and Microbiology.
* Gowning and strict adherence to GMP rules are required for work in production zones.
Profile Requirements
Must-Have
Education & Background
* Scientific degree:
o Master’s degree in biology, chemistry, biochemistry, engineering or related field,
o 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).
Technical & Professional Skills
* 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).
On-Site & GMP Constraints
* Mandatory and regular presence in production areas.
* Full compliance with GMP requirements: gowning procedures, hygiene rules, no jewelry/piercings, respect of classified zones, etc.
Languages
* 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:
o SAP
o LIMS
o Deviation management tools
o OP Center (electronic batch records)
Ideal Candidate
* Experienced scientific profile, comfortable in a pharmaceutical production environment.
* Able to manage deviations end-to-end with minimal supervision.
* At ease both on the shop floor (Gemba, investigations) and with documentation work (writing, analysis).
* Pragmatic, results-driven, and able to propose realistic corrective and preventive actions.
* Fully aligned with GMP constraints and on-site presence requirements.
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.