Overview
Compliance Support Pharma [F/M/X] Jobs in Braine-l’Alleud, Walloon Region, Belgium at Amaris Consulting
Title: Compliance Support Pharma [F/M/X]
Company: Amaris Consulting
Location: Braine-l’Alleud, Walloon Region, Belgium
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
- 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).
- 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.
- 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).
- 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:
- 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).
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:
- SAP
- LIMS
- Deviation management tools
- 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.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
