CSV/IT Quality Specialist

• Are you a driven expert in Computerized System and IT Quality, do you have a strong IT affinity, and do you want to play a key role in an international, innovative environment? Then this challenge is for you As a CSV/IT Quality Specialist, you are the driving force behind the quality, compliance and validation of our IT systems and processes. You will work in a dynamic, regulated environment where your expertise directly contributes to the reliability and security of our digital infrastructure and operations.  You are the central point of contact for GxP compliance (GAMP 5, 21 CFR Part 11, ICH Q10) and audit readiness.

What will you do

System Lifecycle & Validation:

• You monitor and maintain validation strategies and documentation for our IT systems
• You will perform risk assessments for digital solutions and ensure that they meet the highest quality standards
• You draw up validation reports and manage validation files from A to Z
• You work closely with quality managers, system owners and business owners

Process and Documentation Management:

• You manage IT procedures (SOPs) and manuals in the quality documentation system
• You ensure timely updates of documentation, you handle change requests, and ensure correct archiving of documentation
• You are responsible for optimizing the processes and associated procedures; you take the lead in developing, formalizing (in SOP or manual) and managing (maintenance) Digital processes
• You monitor and verify the correct execution of the procedures, you oversee the correct and timely execution of periodic reviews and tasks.
• You maintain learning curricula and make adjustments based on changes to global and local procedures.

Change Control & Compliance:

• You are an expert in the change control processes and you ensure the creation, correct execution, compliance review & approval of all changes
• You represent IT in weekly change meetings and closely follow up on actions
• You carry out impact analyses in the event of changes and monitor compliance with internal procedures

Deviation and CAPA management:

• You are an expert in the deviation and CAPA processes and, in consultation with the IT experts, you ensure creation, correct execution, compliance review & approval

Audit Support & Inspection Readiness:

• You are the first point of contact for GxP audits and inspections by regulators
• You prepare validation files and audit documentation and ensure that everything is inspection-ready
• You support supplier audits and act as a subject matter expert for validation methodology

Periodic tasks:

• You maintain the IT planning and provide KPI reporting
• You manage the official overview of all computer systems and the IT supplier list

What do you bring?

• Proven experience with Computerized System Validation (CSV) and system lifecycle methodologies
• Strong knowledge of GAMP 5, 21 CFR Part 11, ICH Q10 and EU Annex 11
• You like to understand, optimize, and document processes
• Experience with deviation, CAPA, change control processes and documentation management in a regulated (GxP) environment
• Knowledge of risk-based validation and data integrity principles (ALCOA+)
• Experience with quality documentation systems and/or ticketing systems is a plus
• You are accurate, compliance-oriented and enjoy working independently
• You communicate fluently in both Dutch and English

What makes you extra strong?

• Knowledge of risk and compliance frameworks within digital/IT environments
• Experience with SaaS validation and cloud-based systems
• Certificering in GAMP 5 of CSV
• Experience with audit and inspection readiness