Job Title: Analytical System & Data Integrity Specialist

Start Date: Immediate

End Date: Not specified

Location: Belgium

Responsibilities:

• Act as a Data Integrity and analytical systems expert, focusing on Empower, SoftMax Pro, and other systems.
• Support scientists in compliant system use, adhering to ALCOA+ principles.
• Perform data integrity checks, audit trail reviews, and access/roles verification.
• Participate in investigations, including deviations, root cause analysis, and CAPAs.
• Lead or contribute to the harmonization of practices across teams.
• Work in a project-management mode, including reporting, structured approach, and workshops.
• Support inspection readiness and audits.

Overall: A mix of hands-on operational work, coordination, and continuous improvement.

Must Have:

• Strong hands-on expertise with Empower (critical) and ideally SoftMax Pro.
• Solid experience in a pharmaceutical environment (GxP mandatory).
• Deep understanding of Data Integrity (ALCOA+, 21 CFR Part 11).
• Experience in analytical laboratory systems (practical, not theoretical).
• Ability to define rules and governance with a system administration mindset.
• Strong stakeholder management and ability to challenge teams.
• Structured and project-oriented mindset with clear reporting.

Nice to Have:

• Experience with SoftMax Pro or other analytical systems.
• Exposure to system validation, audit preparation, and CAPA management.
• Basic French (to interact with some users), English mandatory.