Remote QA-CSV Specialist - Validation & Data Integrity

Amaris Consulting | Part of Mantu; Beerse; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting, part of Mantu, is seeking a QA-CSV Specialist to provide independent quality oversight and practical CSV support for execution systems used in GxP manufacturing. You will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to keep validation activities risk-based, traceable, and inspection-ready.

In this role you will review validation deliverables, assess changes, incidents, deviations, and CAPAs for impact on product

Qualifications

• Experience with lifecycle documentation, testing, change control, and deviation management.
• Experience with GxP-regulated computerized systems.
• Knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations.

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.
• Apply and promote a pragmatic, risk-based validation approach focused on critical functions, data, interfaces, and controls.
• Assess data integrity controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention, and data transfer.
• Support data-flow mapping and clarify system boundaries, interfaces, critical records, metadata, and control ownership.
• Support periodic reviews, inspection readiness, and audit or inspection questions for assigned systems.
• Communicate quality risks clearly, challenge constructively, and elevate material compliance concerns when required.

Skills

CSV validation

Quality assurance

GxP knowledge

Risk-based validation

Data integrity

Lifecycle documentation

English and Dutch fluent

Tools

SIMATIC Logon

Active Directory

Patch management

Backup and restore

Job description

Amaris Consulting, part of Mantu, is seeking a QA-CSV Specialist to provide independent quality oversight and practical CSV support for execution systems used in GxP manufacturing. You will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to keep validation activities risk-based, traceable, and inspection-ready.

In this role you will review validation deliverables, assess changes, incidents, deviations, and CAPAs for impact on product