Qualified Person & Quality Lead – Batch Release

airliquidehr; Schelle; Sur place; EUR 110 000 - 160 000; Plein temps

Résumé du poste

Air Liquide Medical Ltd. NV in Schelle seeks a Quality Manager & Qualified Person to lead batch release and regulatory compliance for medicinal gases, onsite and remotely for additional sites.

You will manage a 7-person quality team, ensuring GMP adherence and driving site projects across Europe. The role requires a Master’s in Pharmacy with a QP number and 8–10 years of QP experience in pharma manufacturing, with Dutch and English fluency.

Qualifications

• Master's degree in Pharmacy / Pharmaceutical Sciences with QP number.
• 8 to 10 years of experience as a Qualified Person (QP) in a pharmaceutical manufacturing and QC environment.
• Fluent in Dutch and English (written and spoken); knowledge of French is a strong asset.

Responsabilités

• Act as the QP for the manufacturing site in Schelle, ensuring regulatory compliance and timely batch release of medicinal products.
• Act as the QP remotely for the filling of road tankers with cryogenic medicinal gases across two additional Belgian sites.
• Oversee quality control activities and certify that each production batch has been manufactured and checked in accordance with GMP and MA.
• Manage, coach, and guide a team of 7 members including Backup QP and Lab staff; oversee daily batch release and investigations.
• Lead site pharma projects: validation of new manufacturing processes, transfer of analytical methods, and site launches for multiple European countries.
• Supervise qualification and calibration programs for laboratory equipment and instruments.
• Ensure continuous compliance with local and European pharmaceutical regulations; participate in audits and drive quality improvements.
• Collaborate with the Pharmaceutical Affairs Director and other stakeholders to align quality objectives with corporate strategy.

Connaissances

Batch release

Method validation

Process validation

GMP/GLP

Deviation management

Root-cause analysis

Leadership

Communication skills

Analytical mindset

Project leadership

Formation

Master's degree in Pharmacy / Pharmaceutical Sciences

QP certification

Outils

HPLC

LIMS

Description du poste

Air Liquide Medical Ltd. NV in Schelle seeks a Quality Manager & Qualified Person to lead batch release and regulatory compliance for medicinal gases, onsite and remotely for additional sites.

You will manage a 7-person quality team, ensuring GMP adherence and driving site projects across Europe. The role requires a Master’s in Pharmacy with a QP number and 8–10 years of QP experience in pharma manufacturing, with Dutch and English fluency.