QA Compliance Specialist - Master Data & Documentation (Freelance possible)

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

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.

Your profile

• Bachelor’s degree in a scientific field, preferably laboratory, nutrition or health sciences.
• Experience in a regulated environment is a plus.
• Proficiency in computer systems and the ability to work accurately with digital documentation.
• Strong communication skills and the ability to collaborate effectively across teams and with external partners.
• You work in an organized, timely and accurate manner.
• You value inclusion and contribute to a respectful working environment.

Offer

You will be part of a growing Belgian SME where initiative and personal development are encouraged. We will provide you with an enjoyable work environment with fun colleagues. We will work out a career plan with you, with attention and a budget for extra education/certification. You can count on an attractive salary, supplemented with extra-legal benefits, including a company car.
(Freelance is also possible)