Analytical Systems & Data Integrity Specialist

Start Date: ASAP

End Date: 31/12/2027

Location: Antwerp

Responsibilities:

• Serve as a Data Integrity and analytical systems expert, particularly with Empower and SoftMax Pro.
• Support scientists in compliant system use, adhering to ALCOA+ principles.
• Conduct 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.
• Operate in a project-management mode, including reporting, structured approaches, and workshops.
• Support inspection readiness and audits.

Qualifications and Experience:

• Minimum of 3–5 years of experience in a similar role.
• Strong hands-on expertise with Empower is critical; experience with SoftMax Pro is ideal.
• Solid experience in a pharmaceutical environment with GxP requirements.
• Deep understanding of Data Integrity, including ALCOA+ and 21 CFR Part 11.
• Practical experience with analytical laboratory systems.
• Ability to define rules and governance with a system administration mindset.
• Strong stakeholder management skills and the ability to challenge teams.
• Structured and project-oriented mindset with clear reporting capabilities.

Desired Skills:

• Experience with SoftMax Pro or other analytical systems.
• Exposure to system validation, audit preparation, and CAPA management.
• Basic proficiency in French is beneficial; English is mandatory.

Work Environment:

• Hybrid model with on-site presence required depending on business needs, such as workshops.
• Full-time preferred, with the possibility of a 4-day work week.

Interview Process:

• Initial interview with the hiring manager.
• Potential second interview with a technical expert to assess systems knowledge, particularly Empower.
• Agency participation in interviews is accepted.