QA-CSV Specialist: Validation & Data Integrity Lead

AMARIS GROUP SA; Beerse; Hybrid; EUR 60,000 - 100,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a QA-CSV Specialist to provide independent quality oversight for execution systems within a GxP environment. You will collaborate with Execution Systems, Automation, Engineering, IT, and business representatives to ensure validation activities remain risk-based, traceable, and inspection-ready.

You will review and approve validation deliverables such as impact assessments, validation plans, requirements, risk assessments, specifications, test documentation,

Qualifications

• Must have experience in CSV, validation, QA, automation, or computerized systems within a GxP-regulated environment (typically 4–7 years).
• Practical experience with lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state.
• Experience with manufacturing, monitoring, automation, or infrastructure-related computerized systems.
• Solid knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations including PIC/S guidance.

Responsibilities

• Provide QA-CSV support throughout the system lifecycle, including projects, changes, operation, periodic review, and retirement.
• Review and approve validation deliverables such as impact and compliance assessments, validation plans, requirements, risk assessments, specifications, test documentation, traceability, and summary reports.
• Assess changes, incidents, deviations, defects, and CAPAs for impact on product quality, patient safety, data integrity, and the validated state.
• Communicate quality risks clearly and elevate material compliance concerns when required.

Skills

CSV validation

Quality assurance

GxP regulatory

Lifecycle documentation

Risk-based validation

Tools

Active Directory

SIMATIC Logon

Group policies

Backup & restore

File-transfer services

Job description

Amaris Consulting is seeking a QA-CSV Specialist to provide independent quality oversight for execution systems within a GxP environment. You will collaborate with Execution Systems, Automation, Engineering, IT, and business representatives to ensure validation activities remain risk-based, traceable, and inspection-ready.

You will review and approve validation deliverables such as impact assessments, validation plans, requirements, risk assessments, specifications, test documentation,