Quality Assurance Specialist

Job Title: Computerized Systems Validation (CSV) Specialist

About the Role

We are looking for an experienced Computerized Systems Validation (CSV) Specialist to ensure compliance with all CSV-related regulatory requirements throughout the full life cycle of computerized systems — from concept and project initiation to operational use and retirement. In this role, you will review and approve validation documentation, advise on cGMP aspects of new projects, and serve as a key link between IT, engineering, and quality teams. You will also play a vital role in audits, inspections, and continuous improvement of CSV processes.

Key Responsibilities

• Ensure all CSV-related regulatory requirements are met throughout the entire system life cycle (concept, project, operational, and retirement phases).
• Review and approve CSV documents such as SOPs, user requirements, impact/risk analyses, validation plans, and test protocols to maintain regulatory compliance.
• Collaborate with IT and engineering teams, advising on CSV activities and safeguarding cGMP compliance in new projects.
• Address and follow up on deviations during CSV activities.
• Evaluate incidents related to computerized systems, propose corrective/preventive actions, and assess any potential product quality impact.
• Prepare periodic reports on quality system compliance.
• Prepare for and participate in audits and inspections.
• Follow up on CSV-related findings from internal/external audits and quality initiatives.
• Maintain up-to-date knowledge of international CSV regulations, guidelines, and industry developments, implementing improvements where applicable.

Requirements

• In-depth knowledge of cGMP regulations: 21 CFR Part 11, 21 CFR 210, 21 CFR 211, EU Directives 75/319/EEC & 2003/94/EC, EU Volume 4, Annex 11, and related GMP guidelines.
• Solid understanding of GAMP principles (including Global Information Systems, IT Infrastructure Control & Compliance, risk-based approaches to electronic records/signatures, validation of laboratory systems, and GxP testing).
• Knowledge of software development and testing processes.
• Experience with quality auditing and software quality metrics.
• Ability to manage multiple projects simultaneously.
• Strong independent working skills combined with the ability to collaborate in cross-functional teams.
• Excellent communication, project management, and problem-solving skills.
• Prior QA experience is required.

Languages

• Fluent in English (written and spoken)
• Fluent in Dutch

Practical’s

• Location: Beerse, Belgium
• Start Date: ASAP
• Duration: +4 months
• Work Model: Full-time, on-site presence required

Interested or know someone who might be?

Send your CV or inquiries to e.cabral@panda-int.com to apply or learn more.