QA - CSV Specialist

QA-CSV Specialist.

Location: Beerse, Belgium.

Duration of the contract: Until 31 December 2027.

Hours per week: 40 per week.

Contract: Fixed-term Employee Payroll only (No B2B / No Freelancers). Imagine your next project working alongside industry leaders to elevate the standards of healthcare innovation. We are looking for a focused and experienced QA-CSV Specialist to join our team in Beerse. In this role, you will provide critical quality oversight and ensure that our execution systems for GxP manufacturing are both efficient and rigorously compliant.

Roles and responsibilities: You will play a crucial role in maintaining the validated state of our systems and supporting the lifecycle management of our critical manufacturing technology.

This will involve: providing QA-CSV support throughout the system lifecycle, including projects, changes, operation, periodic review and retirement; reviewing and approving validation deliverables such as impact and compliance assessments, validation plans, requirements, risk assessments, specifications, test documentation, traceability and summary reports; assessing changes, incidents, deviations, defects and CAPAs for impact on product quality, patient safety, data integrity and the validated state; applying and promoting a pragmatic, risk-based validation approach focused on critical functions, data, interfaces and controls; assessing data integrity controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention and data transfer; supporting data-flow mapping and clarifying system boundaries, interfaces, critical records, metadata and control ownership; supporting periodic reviews, inspection readiness and audit or inspection questions for assigned systems; and communicating quality risks clearly, challenging constructively and escalating material compliance concerns when required.

How to succeed: To thrive in this role, you should have a solid foundation in computer systems validation and a pragmatic approach to problem-solving.

You will also bring: a Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences or a comparable technical or scientific discipline; typically 4-7 years of relevant experience in CSV, validation, quality assurance, automation or computerized systems within a GxP-regulated environment; 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; fluent English (Dutch is an advantage for local stakeholder interaction); and experience with PLC/SCADA, industrial automation networks, shop-floor systems or particle monitoring solutions, Active Directory, group policies, SIMATIC Logon, patching, antivirus, backup and restore, monitoring or file-transfer services, and data-flow mapping, data integrity risk assessments, periodic reviews or inspection support.

Benefits: This role offers a very competitive hourly rate. This contract will run until 31 December 2027.