QA Compliance & Documentation Specialist

EngiFlex BV; Puurs; Remote; EUR 42,000 - 64,000; Full time

Benefits offered by this job

Company car

Education budget

Career development plan

Job summary

EngiFlex BV is seeking a QA Compliance Specialist to support quality compliance at a Puurs, Belgium site. You will help ensure activities align with cGxP requirements, data integrity, and regulatory standards.

You will review master data, support documentation, and assist with audits and regulatory inspections. The role emphasizes accurate digital documentation, cross-functional collaboration, and maintaining the quality management system.

Qualifications

• Bachelor’s degree in a scientific field; preferably laboratory, nutrition or health sciences.
• Experience in a regulated environment is an asset.
• Proficient with digital documentation and computer-based systems.
• Clear communication and collaboration with colleagues and external stakeholders.
• Organised, precise and able to meet deadlines.
• Knowledge of QA processes, GMP, data integrity and quality management systems.

Responsibilities

• Review and approve new product codes and master data in SAP and other local systems by cross-checking regulatory, manufacturing and artwork data.
• Support the maintenance of site licences and declarations.
• Prepare and coordinate statements, certificates of analysis and other formal documents for GMP and regulatory submissions.
• Organise the legalisation and notarisation of official documents.
• Support internal and external audits as well as regulatory inspections.
• Keep assigned procedures accurate, up to date and aligned with operational needs.
• Work with archival, document management and lifecycle systems.
• Contribute to the change control process and follow up approvals with external parties.
• Help maintain the quality management system and support compliance with site quality indicators.

Skills

QA processes

GMP

Data integrity

Documentation management

Regulatory knowledge

Stakeholder collaboration

Education

Bachelor's degree in a scientific field

Tools

SAP

Document management systems

Job description

EngiFlex BV is seeking a QA Compliance Specialist to support quality compliance at a Puurs, Belgium site. You will help ensure activities align with cGxP requirements, data integrity, and regulatory standards.

You will review master data, support documentation, and assist with audits and regulatory inspections. The role emphasizes accurate digital documentation, cross-functional collaboration, and maintaining the quality management system.