Our client is a global leader in life sciences, committed to innovation, quality, and compliance across all areas of drug development and manufacturing. To strengthen their QA/CSV team, we are looking for a CSV Specialist who will ensure compliance of computerized systems throughout their lifecycle and play a key role in regulatory adherence and inspection readiness.

Responsibilities

• Ensure all CSV-related regulatory requirements are fulfilled during the entire system lifecycle (concept, project, operation, retirement).

• Review and approve CSV documentation (SOPs, URS, impact/risk analyses, validation plans, test protocols) to maintain compliance with global regulations, guidelines, and company standards.

• Collaborate with IT and Engineering teams to support the introduction of new systems/processes, advising on CSV activities and ensuring cGMP aspects are safeguarded.

• Investigate and follow up on deviations and incidents related to computerized systems; define and implement CAPAs where required.

• Prepare for and support system audits and inspections, including follow-up of audit findings and CSV-related initiatives.

• Provide periodic compliance reports and contribute to continuous improvement within the CSV program.

• Maintain up-to-date knowledge of international CSV regulations and guidelines and proactively implement best practices.

Profile

• Strong knowledge of cGMP regulations (21CFR11, 21CFR210/211, EU Directives, Volume 4 Annex 11, GMP Guidelines).

• Experienced with GAMP principles (including IT infrastructure control, electronic records/signatures, laboratory systems, risk-based approaches).

• Background in software development/testing processes, quality auditing, and software quality metrics.

• Proven QA experience in a GxP environment.

• Skilled in multi-tasking, problem solving, and project management; comfortable working both independently and in cross-functional teams.

• Strong communication skills with the ability to influence across departments.

Practicalities

• Location: Beerse, Belgium

• Contract: EOY 2025

• Language: Fluent English

Interested?
If you are a CSV professional looking to contribute to high-impact projects in a global life sciences environment, we’d love to hear from you. Apply now to discuss further details.