Senior QP & Quality Lead — GMP Batch Release

Air Liquide Healthcare; Schelle; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives.

In Schelle, the Qualified Person will take full responsibility for batch release and GMP compliance at the European production facility, while also remotely overseeing two other Belgian sites. You will lead a 7-person on-site team, drive validation projects, and manage audits, deviations, CAPAs, and product

Qualifications

• Master's degree in Pharmacy / Pharmaceutical Sciences with QP number.
• 8 to 10 years of experience as a Qualified Person (QP) in pharmaceutical manufacturing and QC environment.

Responsabilités

• Act as the Qualified Person (QP) for the Schelle site, ensuring full regulatory compliance and timely batch release of medicinal products.
• Act as the Qualified Person (QP) remotely for 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 per GMP and MA.
• Lead a 7-person team and manage deviations, OOS investigations, CAPAs, self inspections and product quality complaints.
• Lead site pharma projects: validation of new manufacturing processes, implementation of new analytical methods, and site launches for about 10 countries in Europe.

Connaissances

QP responsibilities

Batch Release

GMP

GLP

Deviation management

OOS/CAPA

Process validation

Method validation

Leadership

Communication

Project leadership

Problem solving

Formation

Master's degree in Pharmacy / Pharmaceutical Sciences with QP number

Description du poste

Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives.

In Schelle, the Qualified Person will take full responsibility for batch release and GMP compliance at the European production facility, while also remotely overseeing two other Belgian sites. You will lead a 7-person on-site team, drive validation projects, and manage audits, deviations, CAPAs, and product