GxP QA Compliance Specialist - GMP, Audits & Documentation

EngiFlex BV; Puurs; Hybrid; EUR 52,000 - 75,000; Full time

Benefits offered by this job

Company car

Education budget and career plan

Freelance is possible

Job summary

EngiFlex BV in Puurs, Belgium, is seeking a QA Compliance Specialist to support the Quality Management System in a regulated production environment. The role focuses on ensuring site and product activities comply with cGxP, data integrity, and applicable regulations to deliver high-quality medicines.

You will review master data in SAP, maintain licenses and declarations, prepare statements and certificates for GMP submissions, assist audits, manage documents, and support change control and

Qualifications

• Bachelor’s degree in a scientific field.
• Experience in a regulated environment is a plus.
• Proficiency with digital documentation and computer systems.
• Strong communication and collaboration across teams and with external partners.
• Organized, timely and accurate work ethic.
• Value inclusion and contribute to a respectful working environment.

Responsibilities

• Review and approve creation of new product master data codes in SAP and local systems.
• Maintain site licenses and declarations for GMP and regulatory submissions.
• Prepare statements, certificates of analyses and other formal documents for regulatory submissions.
• Coordinate legalization/notarization of documents where required.
• Manage document management and archival systems; support change control activities.
• Assist audits and regulatory inspections and keep procedures up to date; coordinate with external parties.

Skills

QMS knowledge

cGxP knowledge

Data integrity

Documentation management

Cross-team collaboration

Strong communication

Education

Bachelor’s degree in a scientific field

Job description

EngiFlex BV in Puurs, Belgium, is seeking a QA Compliance Specialist to support the Quality Management System in a regulated production environment. The role focuses on ensuring site and product activities comply with cGxP, data integrity, and applicable regulations to deliver high-quality medicines.

You will review master data in SAP, maintain licenses and declarations, prepare statements and certificates for GMP submissions, assist audits, manage documents, and support change control and