Quality Assurance Lead

Il y a 5 heures

Zemst, Flanders, Belgique airliquidehr Temps plein
h3How will you CONTRIBUTE and GROW? /h3pAs Quality Assurance Lead, you are part of the Benelux Pharmaceutical / Quality Department and you report to the Quality Safety Manager Benelux. /ppYou 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. /ppYou lead the following processes: /pulliDocument management /liliComplaint and CAPA management /liliPreparation of the external audits / inspections /liliInternal auditing /liliManagement of change /liliSupplier Qualification /li /ulpand keep them up to date by: /pullimanaging the version of the manuals, procedures and forms ; /lilicreating and following the Corrective and Preventive actions with the concerned managers ; /lilifollowing the external complaints and animating their resolution with the concerned departments ; /liliperforming internal audits ; /lilipreparing external inspections and following the related action plans ; /lilianimating the management of change process ; /lilibeing involved in the training qualification process ; /liliraising quality awareness among the personnel ; /lilimaintaining inventory integrity in Zemst by monitoring storage conditions, managing expiry dates through FEFO rotation, and overseeing pest control protocols;. /lilibeing part of the supplier's qualification and evaluation process by setting up the criteria and by following-up the supplier documentation. /li /ulpYou perform the GDP self-inspections on our sites where we store medicines and medical devices (under the responsibility of the Responsible Person). /ppYou follow and check the GMP production activity in Zemst (under the responsibility of the Qualified Person). /ppAs 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. /ph3Are you a MATCH? /h3pYour profile: /pulliMaster in Science or equivalent /lili3-5 years professional experience with at least a first experience in a quality environment related to medical devices and/or medicines. /liliExcellent transversal leadership and structuring qualities. /liliOpen personality, no-nonsense, reliable. /liliGood communication and social skills. Can influence others positively, easily obtains the cooperation of others, cares about people as well as results. /liliCommand of the Dutch and English language in word and writing. French is a plus. /liliPragmatic, 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. /liliActs according to plan and sets priorities, makes efficient use of methods, systems and resources. /liliAnalytical, helicopter view, flexible (not a black and white thinker). /liliTeam player, stress resistant, and steadfast. /li /ulp#LI-MC1 /ppbOur Differences make our Performance /b /ppAt 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. /ppWe 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. /p