Remote QA-CSV Specialist – Validation & Compliance

MANTU GROUP SA; Beerse; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

MANTU GROUP SA is seeking a QA-CSV Specialist to provide independent quality oversight and practical CSV support for GxP execution systems. You will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to ensure validation activities are risk-based, traceable, and inspection-ready.

The role covers lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state, with emphasis on data integrity

Qualifications

• Experience in CSV, validation, quality assurance, 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.
• Good working knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and recognized 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.
• 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

Automation

GxP

Tools

Active Directory

SIMATIC Logon

Patch Management

Antivirus

Backup and Restore

Job description

MANTU GROUP SA is seeking a QA-CSV Specialist to provide independent quality oversight and practical CSV support for GxP execution systems. You will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to ensure validation activities are risk-based, traceable, and inspection-ready.

The role covers lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state, with emphasis on data integrity