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:
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.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
