Who are we?
Amaris Consulting
is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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
Job Description
Mission Overview
Support the successful
implementation of automated and computerized systems within clinical laboratories
and central teams by providing quality assurance oversight. Ensure compliance with regulatory standards and internal quality requirements throughout the system lifecycle, enabling efficient pipeline delivery, audit readiness, and regulatory submissions.
Key Objectives of the Role
* Ensure business processes, equipment, and automated/analytical systems are developed, qualified, and validated in compliance with GCLP, GCP, ISO 9001:2015, and internal standards.
* Deliver QA expertise to cross-functional teams and stakeholders.
* Promote consistent quality practices across projects ("one voice quality") during automation initiatives.
* Review and approve quality-critical documentation related to CSV, GCLP, and GCP activities.
* Support resolution of technical issues, assess quality impacts, and escalate critical matters following company procedures.
Key Responsibilities
* Provide quality oversight for computerized systems and automation projects from design to validation and operation.
* Review and approve validation documentation (e.g., URS, FS, DS, IQ/OQ/PQ, validation plans/reports) from a QA perspective.
* Collaborate with interdisciplinary teams (IT, Lab Operations, Validation, Engineering) to ensure quality integration across the system lifecycle.
* Support deviation, change control, and CAPA investigations related to automated systems.
* Participate in risk assessments using recognized tools and methodologies (e.g., FMEA, HACCP).
* Contribute to internal audits, regulatory inspections, and remediation activities.
* Ensure compliance with 21 CFR Part 11, GAMP 5, GCLP, and GCP requirements.
* Escalate quality-critical issues promptly and support root cause analysis and corrective actions.
Profile Requirements
Experience & Education:
* Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
* 0–3 years of experience in Quality Assurance or CSV within pharmaceutical, biotech, or clinical laboratory environments.
* Hands-on experience with computerized systems validation and equipment qualification processes.
* French and English fluent mandatory
Technical Knowledge:
* Understanding of regulatory frameworks: 21 CFR Part 11, GAMP 5, GCLP, GCP, ISO 9001:2015.
* Familiarity with quality systems: Deviations, Change Control, CAPA, Non-Conformances.
* Knowledge of risk management principles and tools (e.g., risk assessment, impact analysis).
Skills & Competencies:
* Strong analytical and problem-solving abilities.
* Good written and verbal communication skills in English.
* Ability to work in a matrix environment and engage with diverse stakeholders.
* Proficient in Microsoft Office and familiar with electronic document/content management systems.
* Organized, detail-oriented, and able to manage multiple priorities effectively.
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.