QA-CSV Specialist & Checklyst Manager Site Key User

Location: Belgium (On-Site)
Contract End Date: 31 December 2026 / 2027 ( there is one role ending 2026 and one ending 2027)
Function: Quality / Validation
Industry: Pharmaceutical Manufacturing

About 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:

• Validation strategy and planning
• System implementation and qualification
• Change control assessments
• Operational support
• Periodic reviews
• System retirement activities

Systems in Scope

• 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 Activities

Review and approve:

• 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

Quality & Compliance

• 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

Data Integrity & Compliance

Assess controls relating to:

• Audit trails
• User access management
• Electronic records
• Electronic signatures
• Time synchronization
• Data retention
• Backup and restore processes
• Data transfers and interfaces

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

• 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

User & Access Management

• Manage user onboarding activities
• Coordinate training and adoption
• Maintain user access controls
• Support role management activities
• Review segregation of duties requirements

Operational Support

• 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

Performance & Metrics

• Monitor system KPIs
• Identify overdue actions and records
• Drive timely closure of digital records
• Support continuous improvement initiatives
• Improve digital process efficiency across departments

Required Experience

Education

Bachelor's or Master's Degree in:

• Engineering
• Automation
• Computer Science
• Life Sciences
• Biotechnology
• Pharmaceutical Sciences
• Related discipline

Experience

• 4-7+ years within GMP-regulated environments
• Computer System Validation (CSV)
• Quality Assurance
• Validation and Compliance
• Digital Systems Governance
• Pharmaceutical or Biotechnology manufacturing

Hands-On Experience With

• Validation lifecycle management
• Change controls
• Deviations
• CAPAs
• Risk assessments
• Validation documentation
• Quality oversight activities
• Inspection support
• Data integrity assessments

Technical Knowledge Required

Regulations & Guidelines

• EU GMP Annex 11
• FDA 21 CFR Part 11
• GAMP 5
• SDLC principles
• Data Integrity requirements
• PIC/S guidance
• Risk-based validation methodologies

Technical Systems

Experience with some of the following:

• SCADA
• PLC
• MES
• Automation systems
• Process control systems
• Environmental monitoring systems
• Active Directory
• Network services
• Electronic records management systems

Preferred Experience

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

• Siemens SIMATIC Logon
• Manufacturing automation networks
• MES platforms
• Electronic checklists
• Digital workflows
• eLogbooks
• Electronic forms
• Data-flow mapping
• Access governance
• Inspection readiness programmes
• Digital transformation initiatives

Key Skills

• Computer System Validation (CSV)
• Quality Assurance
• Data Integrity
• GMP Compliance
• GAMP 5
• Annex 11
• FDA 21 CFR Part 11
• CAPA Management
• Change Control
• Risk Management
• Validation
• Automation Systems
• PLC
• SCADA
• MES
• User Access Management
• Stakeholder Management
• Digitalization
• Process Improvement

Success Profile

The ideal candidate will be able to:

• Deliver pragmatic and risk-based QA oversight
• Maintain compliance of GxP computerized systems
• Support inspection readiness activities
• 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

Languages: Fluent English required. Dutch is advantageous.