About the mandate
For an international organisation in a regulated environment, you balance IT and quality as a CSV/IT Quality Specialist. You safeguard the validation, documentation and compliance of IT systems and processes, and you are the central point of contact for GxP compliance (GAMP 5, 21 CFR Part 11, ICH Q10) and audit readiness. You manage validation files, IT procedures, change control, deviations and CAPAs, and you work together with quality managers, system owners, business owners and IT experts. This is a full-time assignment in Geel, where you work onsite 2 to 3 days per week.
Responsibilities
- Safeguard and maintain validation strategies and documentation for IT systems
- Carry out risk assessments, draft validation reports and manage validation files
- Manage IT procedures (SOPs) and manuals in the quality documentation system, including updates, change requests and archiving
- Develop, formalise and optimise digital processes, and monitor the execution of procedures and periodic reviews
- Maintain learning curricula based on changes to global and local procedures
- Follow up change control processes, carry out impact analyses and represent IT in weekly change meetings
- Follow up deviation and CAPA processes together with the IT experts
- Act as first point of contact during GxP audits and inspections, prepare audit documentation and support supplier audits
Must-haves
- Proven experience with Computerized System Validation (CSV) and system life cycle methodologies
- Strong knowledge of GAMP 5, 21 CFR Part 11, ICH Q10 and EU Annex 11
- Experience with deviation, CAPA and change control processes and document management in a GxP environment
- Knowledge of risk-based validation and data integrity principles (ALCOA+)
- Accurate, compliance-oriented and able to work independently
- Fluent communication in Dutch and English
Nice-to-haves
- Experience with quality documentation systems and/or ticketing systems
- Knowledge of risk and compliance frameworks within digital/IT environments
- Experience with SaaS validation and cloud-based systems
- Certification in GAMP 5 or CSV
- Experience with audit and inspection readiness
What the employer offers
- Full-time assignment
- Hybrid: 2 to 3 days per week onsite
- Location: Geel
- International, regulated environment
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