Functieomschrijving

📌 QA Compliance Specialist

📝 Job Description Summary

#LI-Hybrid

📍 Location: Puurs, Belgium

Join the QA compliance team and support the correct application of the Quality Management System in a regulated production environment. In this role, you help ensure that site and product-related activities comply with cGxP requirements, data integrity principles, quality standards, and applicable local and international regulations, with the aim of supporting the consistent delivery of high-quality medicines.

📝 Job Description

As part of the QA Compliance team, you provide operational support across systems and quality processes. You review and approve the creation of new product master data codes in SAP and other local systems, based on checks of regulatory, manufacturing and artwork information.

You also support the maintenance of site licenses and declarations, coordinate the preparation of statements, certificates of analyses and other formal documents for GMP and regulatory submissions, and follow up their legalization and notarization where required.

In addition, you work with document management and archival systems, contribute to change control activities, and help prepare for internal and external audits and regulatory inspections. You keep assigned procedures up to date and aligned with operational needs, and you follow up approvals with external parties where needed.