QA New Product Associate
Il y a 2 mois
locations- Louvain-la-Neuve- time type- Full time- posted on- Posted Today- job requisition id- JR00012512- Zoetis est le leader mondial de la santé animale, voué à accompagner ses clients et leurs entreprises. S'appuyant sur plus de 70 ans d'expérience en santé animale, Zoetis découvre, développe, fabrique et commercialise des vaccins et des médicaments vétérinaires, complétés par des produits de diagnostic et des tests génétiques, ainsi que par une gamme de services. Zoetis est au service des vétérinaires, des éleveurs d’animaux de rente et de ceux qui élèvent et prennent soin des animaux de compagnie et de rente, avec la vente de ses produits dans plus de 100 pays.
- Zoetis compte environ 11.000 collègues qui soutiennent nos activités dans les domaines des ventes, de la recherche et du développement, de la fabrication et de diverses fonctions mondiales. Lorsque vous rejoindrez Zoetis, vous aurez l’opportunité d’apprendre, de développer vos compétences et d’enrichir votre carrière de nombreuses manières : formation sur le terrain, travail sur des projets ambitieux ou simple apprentissage entre pairs et managers. Nous bâtissons notre prochaine génération de leaders en investissant dans le développement de nos collègues.
- Position summary
- Assist QA New Product Manager to ensure adequate quality oversight of VMRD building and related GMP activities
- Support new product introduction at LLN as QA contact within new product introduction teams
- Position responsibilities
- Quality oversight of VMRD building and GMP activities
- Support VMRD team during preparation, participation and establishment of CAPA plan during audits and inspections
- Support integration of new GMP guidelines and Zoetis quality standards in routine VMRD procedures
- Review and approval of VMRD SOP, QRM, master batch records, aseptic validations, change controls, deviations
- Maintain VMRD Site Master File and Contamination control Strategy documents
- Support for VMP cleaning and validation up date
- Edit environmental monitoring reports and water reports, analyze data and propose CAPA when appropriate
- Edit deviation and batch notes trending reports, analyze data and support CAPA identification when appropriate
- Collect and share quality topics and metrics for weekly review with VMRD colleagues
- QA contact for new product development and introduction
- Act as QA contact during Co-Development meeting with other Zoetis sites. Provide quality advice and guidance
- Challenge and approve validation documentation associate with new product validation process
- Challenge and approve validation documentation associated with new product cleaning
- Challenge and approve validation documentation associated with new product analytical method validation or transfer
- Review and approve Master and executed batch records associated to drug product (vaccines and biopharma products) pilot batches introductions, including GMP certification of batches for clinical trials
- Review and approve Master and executed batch records associated to drug substances (Antigens and biopharma products) pilot batches production in VMRD2
- Challenge and approve any deviation, change control, laboratory investigation associated with new products pilot batches
- Review and challenge documentation associated with new raw material or new disposable items qualification
- Release new raw materials batches
- Requirements
- Master with scientific orientation (Pharmacist, Bio Eng.,or equivalent)
- Previous experience (3 years) in aseptic (bio) pharma industry and preferably in a QA and or new product introduction technical position
- Good knowledge of cGMP
- Quality and problem solving oriented
- Proven ability to work cross-functionally with other departments and sites
- Ability to work independently and in teams
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks
- Good proficiency in English (written and spoken)
- Knowledge of MS office, LIMS, SAP, Trackwise
- Good knowledge of cleaning and process validation is a plus
- Notre offre:
- Vous ferez partie de notre équipe Quality Operations locale dynamique.
- Vous ferez partie d'un environnement de travail international avec de la place pour l’ownership et le développement personnel.
- Nous offrons un excellent package de rémunération (chèques-repas, écochèques, frais de déplacements, package assurances et Fonds de pension )
- Un équilibre vie privée et vie professionnelle
Full time
- OR:
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