GxP Data Integrity Analyst – Pharma Compliance

AMARIS GROUP SA; Geel; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Job summary

Amaris Consulting in Belgium seeks a Data Integrity specialist to support a key pharmaceutical client. You will review GxP-regulated analytical equipment and associated computerized systems across Manufacturing and QC, ensuring data reliability and compliance under supervision of an experienced project leader.

You will collaborate with site Subject Matter Experts, perform DI reviews, gap assessments, and risk analyses, and contribute to remediation proposals with precise documentation and

Qualifications

• 1-3 years in a highly regulated environment, preferably pharma.
• Familiar with GxP requirements for analytical equipment.
• Strong knowledge of Data Integrity, ALCOA++.
• Understanding of data flows, audit trails, traceability and system controls.
• Knowledge of risk management and ICH Q9.
• Strong analytical skills and attention to detail.

Responsibilities

• Perform Data Integrity reviews of GxP-regulated equipment and systems.
• Conduct gap assessments, data flow mappings, and DI risk assessments.
• Verify interfaces for data generation and transfer accuracy.
• Review audit trails, data traceability, electronic data management, and access controls.
• Assess IT security measures and equipment controls for gaps.
• Document findings and contribute remediation proposals.
• Create, update and review documentation per protocols and templates.
• Collaborate with site SMEs and cross-functional teams on compliant data management.

Skills

Data Integrity

GxP Knowledge

ALCOA++

Risk Assessment

Documentation Skills

Analytical Skills

Job description

Amaris Consulting in Belgium seeks a Data Integrity specialist to support a key pharmaceutical client. You will review GxP-regulated analytical equipment and associated computerized systems across Manufacturing and QC, ensuring data reliability and compliance under supervision of an experienced project leader.

You will collaborate with site Subject Matter Experts, perform DI reviews, gap assessments, and risk analyses, and contribute to remediation proposals with precise documentation and