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.
*
o GAMP5, CSV (Computerized System Validation), and CSA (Computer Software Assurance).
o 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.