QA CSV & Digital Compliance Consultants
Location: Belgium (Beerse / Ghent)
Contract: Freelance Consultant
Industry: Pharmaceutical & Biotechnology
Overview
We are supporting multiple strategic programmes within a global pharmaceutical environment and are looking to engage experienced QA-CSV, Digital Compliance and Computerised Systems Validation professionals.
Opportunities are available across both operational and programme-level assignments, supporting manufacturing systems, Industrial IT environments, MES deployments, Data Integrity initiatives, and GxP-regulated digital transformation programmes.
Whether your background is in hands-on CSV execution, Industrial IT compliance, validation governance, or leading large-scale MES implementation programmes, we would be interested in speaking with you.
Key Responsibilities
- Provide QA and CSV oversight for GxP computerised systems.
- Support validation lifecycle activities including risk assessments, testing, deployment, and system release.
- Review and approve validation documentation, protocols, reports, and quality records.
- Ensure compliance with GAMP 5, EU GMP Annex 11, 21 CFR Part 11, and Data Integrity requirements.
- Support investigations, deviations, CAPAs, change controls, and compliance assessments.
- Participate in deployment readiness, validation governance, and inspection readiness activities.
- Collaborate with Manufacturing, Engineering, Automation, Digital, IT and Quality stakeholders.
- Contribute to digital transformation, MES, Industry 4.0, and computerised systems compliance programmes.
Typical Areas of Expertise
- Computer System Validation (CSV)
- QA-CSV
- Data Integrity
- Industrial IT / Operational Technology (OT)
- MES Validation
- PAS-X
- PharmaSuite
- Syncade
- GAMP 5
- Annex 11
- 21 CFR Part 11
- Change Control
- CAPA Management
- Deviation Management
- Audit Trail Review
- Validation Lifecycle Management
- Digital Quality Systems
- GMP Compliance
Requirements
- Experience working within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- Strong understanding of Computer System Validation and GxP compliance requirements.
- Knowledge of Data Integrity principles and risk-based validation approaches.
- Experience supporting or leading validation activities for manufacturing, laboratory, automation, or enterprise systems.
- Excellent stakeholder management and communication skills.
- Fluent English required.
- Dutch language skills are highly advantageous.
Ideal Backgrounds
We are interested in professionals currently working as:
- QA-CSV Consultant
- CSV Engineer
- CSV Specialist
- Validation Lead
- QA-CSV Lead
- Industrial IT Compliance Consultant
- Industrial IT Specialist
- Data Integrity Consultant
- MES Validation Lead
- Digital Quality Consultant
- Computerised Systems Compliance Specialist
- CSV Programme Lead
- Validation Manager
- Computer Systems Quality Lead
This opportunity is suitable for professionals ranging from experienced CSV specialists through to senior QA-CSV and validation leaders looking to support strategic pharmaceutical manufacturing and digital transformation programmes.