QA-CSV Specialist & Site Key User

Project overview

QA-CSV Specialist & Checklyst Manager Site Key User

Project details

Belgium (On-Site)

Contract End Date: 31 December * ( there is one role ending 2026 and one ending 2027)

Function: Quality / Validation

Industry: Pharmaceutical ManufacturingAbout the Role

We are seeking a QA-CSV Specialist & Checklyst Manager Site Key User to support a leading pharmaceutical manufacturing site. This is a hybrid position combining Computer System Validation (CSV) quality oversight with governance and administration of a site-wide digital checklist platform.

The successful candidate will provide QA-CSV support for GxP-regulated computerized systems while acting as the Site Key User for Checklyst Manager, ensuring digital workflows are implemented, governed, and maintained in compliance with GMP and data integrity requirements.

This role offers an excellent opportunity to work at the intersection of Quality, Validation, Digitisation, and Manufacturing Operations.Key Responsibilities

QA-CSV Support (50%)

Quality Oversight of Computerised Systems

Provide QA support across the full computerised system lifecycle including:

Systems in Scope

Validation Activities

Review and approve:

Quality & Compliance

Data Integrity & Compliance

Assess controls relating to:

Checklyst Manager Site Key User (50%)

The Site Key User will act as the primary business representative for Checklyst Manager, supporting the site's transition from paper-based processes to controlled digital checklists.Digital Checklist Governance

User & Access Management

Operational Support

Performance & Metrics

Required Experience

Education

Bachelor's or Master's Degree in:

Experience

Hands-On Experience With

Technical Knowledge Required

Regulations & Guidelines

Technical Systems

Experience with some of the following:

Preferred Experience

Candidates with experience in one or more of the following will be highly desirable:

Key Skills

Success Profile

The ideal candidate will be able to:

Languages: Fluent English required. Dutch is advantageous.

• Validation strategy and planning
• System implementation and qualification
• Change control assessments
• Operational support
• Periodic reviews
• System retirement activities
• PLC-based automation systems
• SCADA systems
• Environmental monitoring systems
• Particle monitoring systems
• Manufacturing automation networks
• Active Directory environments
• Data transfer and file management systems
• SIMATIC Logon environments
• Infrastructure monitoring solutions
• Backup and restore platforms
• Validation Plans
• User Requirements Specifications (URS)
• Functional Specifications
• Design Documentation
• Risk Assessments
• IQ/OQ/PQ Documentation
• Test Scripts and Protocols
• Traceability Matrices
• Validation Summary Reports
• Evaluate changes, deviations, incidents and defects
• Assess impact on product quality and patient safety
• Review CAPAs and corrective actions
• Support inspection readiness activities
• Maintain the validated state of computerized systems
• Escalate quality risks where appropriate
• Audit trails
• User access management
• Electronic records
• Electronic signatures
• Time synchronization
• Data retention
• Backup and restore processes
• Data transfers and interfaces
• Coordinate creation of new digital checklists
• Ensure proper configuration and testing
• Manage checklist approval workflows
• Support release of new digital processes
• Ensure GMP-compliant implementation
• Manage user onboarding activities
• Coordinate training and adoption
• Maintain user access controls
• Support role management activities
• Review segregation of duties requirements
• Act as first-line support for system users
• Assist authors, reviewers and approvers
• Coordinate issue escalation with technical teams
• Provide guidance on system usage and best practices
• Monitor system KPIs
• Identify overdue actions and records
• Drive timely closure of digital records
• Support continuous improvement initiatives
• Improve digital process efficiency across departments
• Engineering
• Automation
• Computer Science
• Life Sciences
• Biotechnology
• Pharmaceutical Sciences
• Related discipline
• 4-7+ years within GMP-regulated environments
• Computer System Validation (CSV)
• Quality Assurance
• Validation and Compliance
• Digital Systems Governance
• Pharmaceutical or Biotechnology manufacturing
• Validation lifecycle management
• Change controls
• Deviations
• CAPAs
• Validation documentation
• Quality oversight activities
• Inspection support
• Data integrity assessments
• EU GMP Annex 11
• FDA 21 CFR Part 11
• GAMP 5
• SDLC principles
• Data Integrity requirements
• PIC/S guidance
• Risk-based validation methodologies
• SCADA
• PLC
• MES
• Automation systems
• Process control systems
• Active Directory
• Network services
• Electronic records management systems
• Siemens SIMATIC Logon
• MES platforms
• Electronic checklists
• Digital workflows
• eLogbooks
• Electronic forms
• Data-flow mapping
• Access governance
• Inspection readiness programmes
• Digital transformation initiatives
• Data Integrity
• GMP Compliance
• Annex 11
• CAPA Management
• Change Control
• Risk Management
• Validation
• Stakeholder Management
• Digitalization
• Process Improvement
• Deliver pragmatic and risk-based QA oversight
• Maintain compliance of GxP computerized systems
• Govern digital workflows and checklist systems
• Coordinate multiple stakeholders across Quality, Manufacturing and Engineering
• Drive adoption of digital solutions while maintaining regulatory compliance
• Communicate effectively across all levels of the organization
• Start: date 10/2026
• Duration: 2 months
• Remote: remote
• Location: Beerse, Belgium, BE
• Languages: English