QA Compliance Specialist - Master Data & Documentation

EngiFlex BV; Puurs-Sint-Amands; Híbrido; EUR 60 000 - 90 000; Tempo integral

Resumo da oferta

EngiFlex BV in Puurs, Belgium, seeks a QA Compliance Specialist to support the Quality Management System in a regulated production environment. You will help ensure that site and product activities comply with cGxP requirements, data integrity, and applicable regulations to deliver high-quality medicines.

You will review master data in SAP, support licenses, declarations and regulatory submissions, and assist with document management, change control, and audits.

Qualificações

• Review and approve the creation of new product master data codes in SAP and other local systems.
• Ensure compliance with cGxP requirements and data integrity principles.
• Maintain site licenses and declarations for GMP and regulatory submissions.
• Support change control activities and audits/regulatory inspections.

Responsabilidades

• Provide operational support across QA systems and processes.
• Coordinate preparation of statements, certificates of analyses and related documents.
• Keep procedures up to date and aligned with operational needs.
• Follow up approvals with external parties as needed.

Conhecimentos

GxP familiarity

Data integrity

Regulatory compliance

SAP

Quality systems

Auditing

Ferramentas

Local systems

Descrição da oferta de emprego

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.