Computer System Validation Pharmaceuticals Junior F​/M​/X

Rixensart

Permanent Job

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.

• 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.
• 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.

• 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.

• 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

• 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).

• 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.

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.