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.