Quality Compliance Specialist (Employed or freelance)

EngiFlex BV; Puurs; Remoto; EUR 42.000 - 64.000; Tempo pieno

Vantaggi offerti da questo lavoro

Company car

Education budget

Career development plan

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

QA processes

GMP

Data integrity

Documentation management

Regulatory knowledge

Stakeholder collaboration

Formazione

Bachelor's degree in a scientific field

Strumenti

SAP

Document management systems

Descrizione del lavoro

QA Compliance Specialist

Job summary

As QA Compliance Specialist, you support quality compliance activities at a manufacturing site in Puurs, Belgium. You help ensure that site and product-related activities remain aligned with cGxP requirements, data integrity principles, quality management processes, and applicable local and international regulations.

In this role, you contribute to the correct use of quality systems and documentation processes. You review and approve the creation of new master data codes, verify information across regulatory, manufacturing and artwork systems, and support the preparation of formal compliance documents. You also assist with document lifecycle management, change control and audit readiness.

Key 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.

Your profile

• You hold a bachelor’s degree in a scientific field, preferably laboratory, nutrition or health sciences.
• Experience in a regulated environment is an asset.
• You work accurately with digital documentation and computer-based systems.
• You communicate clearly and collaborate well with colleagues and external stakeholders.
• You are organised, precise and able to meet deadlines.
• Knowledge of QA processes, GMP, data integrity and quality management systems is relevant for this role.

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)