QA Compliance & Master Data Specialist

EngiFlex BV; Puurs-Sint-Amands; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

GxP familiarity

Data integrity

Regulatory compliance

SAP

Quality systems

Auditing

Tools

Local systems

Job description

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.