Quality Assurance Lead

BE11854-HHCBEL Air Liquide Homecare Belgium BV; Zemst; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Air Liquide Homecare Belgium BV in Zemst seeks a Quality Assurance Lead to maintain GDP/ISO 13485 and MDR compliance, oversee the QMS, and coordinate audits and CAPA across the Benelux region. You will lead change, supplier qualification, and training, while ensuring strict inventory integrity including FEFO and pest control at Zemst.

The role demands a Master’s in Science with 3–5 years in a quality environment related to medical devices or medicines, plus strong leadership and communication

Qualifications

• Master in Science or equivalent with 3–5 years in quality environment related to medical devices/medicines.
• Excellent transversal leadership and structuring qualities.
• Open personality, reliable and collaborative.
• Fluent in Dutch and English; French is a plus.

Responsabilités

• Maintain the Quality Management System per GDP and ISO 13485/MDR for the Belgian affiliate.
• Manage document control, complaints and CAPA.
• Prepare external audits/inspections; perform internal audits.
• Lead change management and supplier qualification; monitor manuals and forms.
• Manage expiry dates with FEFO rotation and pest control protocols.
• Support training and qualification processes; raise quality awareness.

Connaissances

Leadership

Quality management

Auditing

CAPA

Document control

GxP

Supplier qualification

FEFO rotation

GMP/GDP knowledge

Dutch language

English language

Formation

Master's degree in Science

Description du poste

How will you CONTRIBUTE and GROW?

As Quality Assurance Lead, you are part of the Benelux Pharmaceutical / Quality Department and you report to the Quality & Safety Manager Benelux. You are responsible to maintain the Quality Management System according to the Good Distribution Practices (GDP - medicines) and ISO 13485 / MDR (Medical Devices as a distributor) in the Home Healthcare Belgian affiliate.

Processes and Responsibilities

• Document management
• Complaint and CAPA management
• Preparation of the external audits / inspections
• Internal auditing
• Management of change
• Supplier Qualification and keep them up to date by: managing the version of the manuals, procedures and forms;
• Creating and following the Corrective and Preventive actions with the concerned managers;
• Following the external complaints and animating their resolution with the concerned departments;
• Performing internal audits;
• Preparing external inspections and following the related action plans;
• Animating the management of change process;
• Being involved in the training & qualification process;
• Raising quality awareness among the personnel;
• Maintaining inventory integrity in Zemst by monitoring storage conditions, managing expiry dates through FEFO rotation, and overseeing pest control protocols;
• Being part of the supplier's qualification and evaluation process by setting up the criteria and by following-up the supplier documentation.
• You perform the GDP self-inspections on our sites where we store medicines and medical devices (under the responsibility of the Responsible Person).
• You follow and check the GMP production activity in Zemst (under the responsibility of the Qualified Person).
• As an important project, you work in close collaboration with the Benelux Quality & Safety Manager in order to harmonize the quality processes between Belgium and the Netherlands.

Are you a MATCH? Your profile:

Master in Science or equivalent 3-5 years professional experience with at least a first experience in a quality environment related to medical devices and/or medicines.

Excellent transversal leadership and structuring qualities.

Open personality, no-nonsense, reliable.

Good communication and social skills.

Can influence others positively, easily obtains the cooperation of others, cares about people as well as results.

Command of the Dutch and English language in word and writing. French is a plus.

Pragmatic, quality and cost conscious. Defines objectives and the means to achieve them, anticipates future situations, draws up work plans and efficient use of available resources or allocates them efficiently.

Acts according to plan and sets priorities, makes efficient use of methods, systems and resources.

Analytical, helicopter view, flexible (not a black and white thinker).

Team player, stress resistant, and steadfast.

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Our Differences make our Performance

At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world. We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.

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