Job description
Mission Description
Within the Quality Assurance department of our client in the Life Sciences industry, you will be responsible for ensuring the compliance and robustness of computerized systems and quality processes in accordance with GxP and regulatory requirements.
You will act as a key interface between QA, IT, and business teams, supporting both validation activities and operational quality topics.
Responsibilities
QA Validation (CSV / GAMP5 / CSA)
Lead and execute Computerized System Validation (CSV) activities in line with GAMP5 and CSA principles.
Prepare and review validation documentation (URS, FS, DS, risk assessments, IQ/OQ/PQ, validation reports).
Ensure that computerized systems are compliant with applicable regulations (GxP, 21 CFR Part 11, Annex 11, data integrity).
Participate in impact and risk assessments for changes affecting computerized systems.
Operational Quality Assurance
Manage and/or support the treatment of deviations, complaints, CAPAs, and change controls.
Ensure timely investigation, root cause analysis, and implementation of effective corrective and preventive actions.
Contribute to the continuous improvement of QA processes and documentation.
Support inspections and internal/external audits related to QA and CSV topics.
Cross-functional Support
Collaborate with IT, engineering, production, QC, and other stakeholders to ensure quality and compliance throughout the system lifecycle.
Provide training and guidance on CSV, GAMP5, and quality processes to project and operational teams.
Profile Requirements
Experience & Technical Skills
7 to 10 years of experience in Quality Assurance within the Life Sciences / Pharmaceutical / Biotech / Medical Devices industry.
GAMP5, CSV (Computerized System Validation), and CSA (Computer Software Assurance).
Management of deviations, complaints, CAPAs, and change controls.
Strong, proven experience in:
Solid understanding of GxP regulations and data integrity requirements.
Experience in a role combining QA validation and QA operational responsibilities.
Languages
Fluent in English and French (spoken and written).
Soft Skills
Strong analytical and problem-solving skills.
Ability to work autonomously while collaborating effectively with cross-functional teams.
Rigorous, organized, and detail-oriented.
Good communication and stakeholder management skills.
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!
