GxP CSV QA Specialist: Validation & Data Integrity

Amaris Consulting | Part of Mantu; Beerse; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

International community

Comprehensive training program

Team events and activities

ESG commitments via WeCare Together

Résumé du poste

Amaris Consulting 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 ensure that validation activities and lifecycle decisions remain risk-based, traceable, and inspection-ready.

You will review validation deliverables, assess changes and CAPAs, apply a pragmatic validation

Qualifications

• Experience in CSV, validation, quality assurance, automation, or computerized systems within a GxP-regulated environment (typically 4-7 years)
• English and Dutch fluent.
• 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
• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces, and supplier documentation
• Ability to understand technical system architecture and translate it into clear validation and quality decisions
• Effective communication, collaboration, and organization skills, with the confidence to challenge while maintaining a solution-oriented approach

Responsabilités

• 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

Connaissances

CSV validation

Quality assurance

Validation lifecycle

GxP regulatory

Data integrity

Outils

Active Directory

SIMATIC Logon

Data transfer services

Description du poste

Amaris Consulting 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 ensure that validation activities and lifecycle decisions remain risk-based, traceable, and inspection-ready.

You will review validation deliverables, assess changes and CAPAs, apply a pragmatic validation