Senior QA Associate Car-t
Il y a 7 mois
Johnson & Johnson (J&J) is op zoek naar een Senior QA Associate aan voor het CAR-T-hub in Europa. De functie zal gevestigd zijn in Gent, België.
CAR-T (chimeric antigen receptor T-cell therapy) is een innovatieve aanpak om kankercellen te elimineren, waarbij gebruik wordt gemaakt van de kracht van het eigen immuunsysteem van de patiënt. Ze worden gecreëerd uit de eigen T-cellen van de patiënt en zijn ontworpen om kankercellen met een specifiek antigeen te elimineren.
Om het CAR-T-programma in EMEA te ondersteunen, heeft J&J twee CAR-T-productiecentra gebouwd in de regio Gent (België). De QC-laboratoria zullen worden beheerd vanuit de bestaande J&J-site in Beerse. CAR-T-onderzoeksmedicatie en commerciële CAR-T-producten worden vervaardigd in de faciliteiten in Gent.
In deze rol rapporteer je aan de QA/QP-organisatie en werk je nauw samen met collega's van Quality Assurances Operations en Quality Control.
De Senior QA Associate, CAR-T Europe, is verantwoordelijk voor het correct afhandelen van product
- en procesgerelateerde onderzoeken, klachten en het beoordelen van batchdocumentatie binnen de gestelde termijnen en in overeenstemming met alle ATMP/GMP-vereisten.
BELANGRIJKSTE VERANTWOORDELIJKHEDEN:
- Ervoor zorgen dat afwijkingen/klachten tijdig en correct worden onderzocht. Afwijkingen/klachten met potentieel effect op patiënten en/of productvoorziening worden op passende wijze geëscaleerd.
- Ervoor zorgen dat adequate corrigerende en preventieve maatregelen (CAPA's) worden gedefinieerd voor onderzoeken met potentieel kwaliteitseffect.
- Ondersteuning bij de voorbereiding, uitvoering en opvolging van inspecties en audits.
- Deelnemen aan de kwaliteitstoezichtprogramma's van de operationele activiteiten door middel van gedocumenteerde QA-goedkeuring van GMP-documentatie en ondersteuning bij de verschillende kwaliteitsoverlegvergaderingen.
- Het opbouwen en onderhouden van effectieve werkrelaties met de verschillende partners en Legend Biotech om afstemming van doelstellingen en resultaten te waarborgen.
- Het waarborgen en beheren van de implementatie en uitvoering van verschillende processen binnen het kwaliteitssysteem.
- Ondersteuning bieden aan de operationele en QA-afdelingen door middel van coaching en/of training.
- Beoordeling van batchdocumentatie en controle van analytische resultaten.
**Qualifications**:
ERVARING EN VAARDIGHEDEN:
- Gecertificeerd Industrieapotheker met mínimaal 3 jaar cross-functionele ervaring in de farmaceutische industrie.
- Diepgaand begrip van productontwikkeling, kwalificatie, verpakking, validatie, testen, vrijgave en distributieprocessen binnen de farmaceutische industrie.
- Actuele kennis en diepgaand begrip van relevante farmaceutische wetgeving met betrekking tot klinische onderzoeken en cGMP-regelgeving met betrekking tot de productie van celtherapieproducten, evenals kennis van de Good Tissue Practices.
- Sterke analytische en besluitvormingsvaardigheden.
- Uitstekende mondelinge en schriftelijke communicatieve vaardigheden om te onderhandelen en communiceren met externe en interne klanten en partners.
- Ervaring met werken met kwaliteitssystemen is vereist.
- Ervaring met aseptische verwerking en technieken is vereist.
- Sterke organisatorische vaardigheden en in staat om te werken in een teamomgeving met een positieve instelling onder enige supervisie.
- Goede schriftelijke en mondelinge communicatieve vaardigheden zijn vereist.
Johnson & Johnson is een werkgever die gelijke kansen biedt en een positieve actie ondersteunt. Alle gekwalificeerde sollicitanten krijgen gelijke kansen voor werkgelegenheid zonder onderscheid te maken op basis van ras, huidskleur, religie, geslacht, seksuele geaardheid, genderidentiteit, leeftijd, nationaliteit of beschermde veteranenstatus en worden niet gediscrimineerd op basis van handicap.
Voor meer informatie over hoe we de algehele gezondheid van onze werknemers ondersteunen gedurende hun welzijn, carrière
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