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89 jobs in Pharmaceuticals / Biotechnology / Chemistry in the Canton of Geneva

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Swedish Orphan Biovitrum AG
Selection
Bioanalytical (Associate) Project Manager (based in Geneva) Key responsibilities Support clinical trial logistics and planning of human sample analysis in the laboratory, as related to bioanalytical activities. Ensure that smooth process of sample analysis is undertaken. Ensure back-up for other coordination members Liaise with different stakeholders (such as Bioanalytical project managers, Lab operators, clinical team, finance,) to maintain project schedules and follow-up project timelines in line with business objectives. Ensure proper and regular Trial Master File filing of documentation and Quality control check Organize Bioanalytical Meetings involving relevant stakeholders, and ensure meeting minutes recording and monitoring of follow-up actions. Review of clinical documentation (Patient’s Informed Consent Form, eCase Report Form, Clinical Protocols, Laboratory Manuals). Perform annual budget forecast preparation, including costs, resources allocation and provide information to the Finance department or Clinical Program Leaders as needed. Project management with external partners for outsourced work, including CRO selection, contracting, documentation review and support for study monitoring and closing. Coordinate CRO oversight meetings, prepare agenda, involve appropriate stakeholders, ensure meeting minutes recording and monitor follow-up actions. Ensure performance of service providers to achieve on time delivery of project milestones, within the budget. Ensure invoices are processed according to internal procedures (or requests from finance department) Participate in the creation, update and/or review of the Quality System documentation to improve/ implement processes in compliance with GCP/ GCLP. Participate in Quality Assurance audits of the bioanalytical facility Participate to the CAPA Plan actions execution as required Cooperate with Quality Assurance in the frame of the inspection readiness preparation Skills and Competencies A Bachelor’s Degree in a scientific discipline is required. At least 3 years of experience of project management in cross-functional projects in either Pharma/Biotech or CRO are required. Project management certification is a plus. Good knowledge of clinical studies, GCLP/ GCP environment. Team player, ability to work with others, to face challenges and solution-oriented. Excellent organizational skills, ability to prioritize tasks and to cover multiple concurrent activities Ability to work under pressure. Excellent communication skills, able to communicate at different levels within the organization. Excellent command of written and verbal English. French an asset.Swedish Orphan Biovitrum AGPlan-les-Ouates
02.04
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Mission Expert AQ - 3x8 - GSK

Kelly Scientific Genève — Suisse romande
04.04. | Temporary | 100%


Kelly Scientifique recherche pour son client GSK Nyon en Suisse romande, un Expert en Assurance Qualité. Poste en équipe 3*8. Début JASAP jusqu'à Fin Décembre...

Mission Expert AQ - 3x8 - GSK


Kelly Scientifique recherche pour son client GSK Nyon en Suisse romande, un Expert en Assurance Qualité. Poste en équipe 3*8. Début JASAP jusqu'à Fin Décembre 2020.
 
Votre mission
Assurer la qualité globale opérationnelle sur les lignes de production : garantir une présence fonctionnelle pour les contrôles en cours de production et résoudre les problèmes en temps réel.
 
Vos responsabilités
 

  • Réaliser les contrôles en cours de production chaque procédé afin d'assurer que les produits sont conformes aux BPF et aux exigences internes
  • Libérer la ligne en s'assurant que tous les points AQ sont conformes aux objectifs
  • Traiter les non-conformités et promouvoir les directives AQ
  • Fournir un support direct pour la gestion des investigations, des déviations et des CAPAs
  • Déployer les solutions globales pharmaceutiques GPS et supporter la performance des procédés
  • Apporter, suggérer et gérer les actions d'amélioration
  • Réaliser la revue des documents pour chaque dossier de lot
  • Réaliser les audits internes BPF
  
Votre profil
  • Pharmacien ou Ingénieur en Chimie, Biologie ou autres sciences
  • Minimum 2/3 an d'expérience en industrie pharmaceutique en production ou qualité
  • Expérience dans un contexte BPF
  • Expérience dans les outils d'amélioration (Lean, 5S,...)
  • Français courant et bonnes connaissances en anglais
   
Votre contact Kelly  
Sophie Darthenay
Conseillère en Life Science
Kelly Scientifique Genève
 

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