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

EngiFlex BV; Puurs-Sint-Amands; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Company car

Budget for extra education/certificat

Zusammenfassung

EngiFlex BV in Puurs, Belgium, is seeking a QA Compliance Specialist to support cGxP requirements, data integrity, and quality standards in a regulated production environment. You will review master data in SAP, maintain licenses, and coordinate documents for GMP submissions.

You will collaborate across teams, keep procedures current, and assist audits and inspections, while fostering an inclusive, organized, and accurate workplace. A company car and education budget are part of the offer.

Qualifikationen

• Bachelor’s degree in a scientific field.
• 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.

Aufgaben

• Review and approve creation of new product master data codes in SAP and other systems based on regulatory, manufacturing and artwork checks.
• Maintain site licenses and declarations, coordinate statements, certificates of analyses and other formal documents for GMP and regulatory submissions.
• Follow up legalization and notarization where required.
• Work with document management and archival systems, contribute to change control activities.
• Help prepare for internal and external audits and regulatory inspections; keep procedures up to date and align with operational needs; follow up approvals with external parties.

Kenntnisse

Communication

Attention to detail

Team collaboration

Regulated environment experience

Ausbildung

Bachelor's degree in a scientific field

Tools

SAP

Jobbeschreibung

QA Compliance Specialist

Job Description Summary

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)