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3 Permanent Biotechnology & pharmaceutical jobs found in Genève, Genève

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    • genève, genève
    • permanent
    Are you looking for a new professional challenge ? Experienced within the Packaging/QA environment ?For a company leader in the pharma sector, we’re looking for a Packaging Quality Manager. The candidate will be part of the Manufacturing Site based in Geneva. Mission: You will manage all the following tasks and responsibilities according to current worldwide GMP and the company’s corporate Quality Management System. You will work 4 days a week including Saturday and 5 days a week during production shutdown.  Activities: - Review batch records (production and packaging) - Review of Syringes sub-contractor batch You’ll Improve, maintain and assure a continuous improvement of the following local Quality Systems to assure the quality  of the product as: -QA oversight of packaging and production area - Manage deviations related to packaging area and participate to investigations related to production and QC  with the concerned functions - Follow up of PQI (Potential Quality Incident), - Participate in complaints investigation and Trackwise approval - Review/approve for issuance of GMP documents related to packaging area (SOP’s, specifications, protocols,  reports..) - Review and approve validation/qualification documentation related to packaging area and Ensure that activities are conform with the company policies and  Corporate Quality directives - Participate in Risk analysis in collaboration with a supportive department. - Auditor in self-inspections and external audits  - Participate as QA representative to projects related to the packaging area. - Manage for her responsibility area regulatory inspection - Perform audit trail review of GMP systems. - Indirect management of investigation teams and risk analysis team - Backup in production deviation management and complaints management Profile : - Bachelor, University degree in Chemistry, or Master degree in Quality Assurance, Quality Control and  Validation Method - At least 4 years of experience in QA environment pharmaceutical industry - Fluency in English (both oral and written) - Extremely motivated, with rigorous work habits and problem-solving skills - Quality commitment, flexibility, initiative, cross functional cooperation behavior- Excellent team player with a strong ability to communicate  If you recognize yourself in this profile and are looking for a new challenge, send us your complete application (letter & CV). We’re looking forward to hearing from you !
    Are you looking for a new professional challenge ? Experienced within the Packaging/QA environment ?For a company leader in the pharma sector, we’re looking for a Packaging Quality Manager. The candidate will be part of the Manufacturing Site based in Geneva. Mission: You will manage all the following tasks and responsibilities according to current worldwide GMP and the company’s corporate Quality Management System. You will work 4 days a week including Saturday and 5 days a week during production shutdown.  Activities: - Review batch records (production and packaging) - Review of Syringes sub-contractor batch You’ll Improve, maintain and assure a continuous improvement of the following local Quality Systems to assure the quality  of the product as: -QA oversight of packaging and production area - Manage deviations related to packaging area and participate to investigations related to production and QC  with the concerned functions - Follow up of PQI (Potential Quality Incident), - Participate in complaints investigation and Trackwise approval - Review/approve for issuance of GMP documents related to packaging area (SOP’s, specifications, protocols,  reports..) - Review and approve validation/qualification documentation related to packaging area and Ensure that activities are conform with the company policies and  Corporate Quality directives - Participate in Risk analysis in collaboration with a supportive department. - Auditor in self-inspections and external audits  - Participate as QA representative to projects related to the packaging area. - Manage for her responsibility area regulatory inspection - Perform audit trail review of GMP systems. - Indirect management of investigation teams and risk analysis team - Backup in production deviation management and complaints management Profile : - Bachelor, University degree in Chemistry, or Master degree in Quality Assurance, Quality Control and  Validation Method - At least 4 years of experience in QA environment pharmaceutical industry - Fluency in English (both oral and written) - Extremely motivated, with rigorous work habits and problem-solving skills - Quality commitment, flexibility, initiative, cross functional cooperation behavior- Excellent team player with a strong ability to communicate  If you recognize yourself in this profile and are looking for a new challenge, send us your complete application (letter & CV). We’re looking forward to hearing from you !
    • genève, genève
    • permanent
    Are you a QA specialist?Are you looking for a new challenge in the pharmaceutical industry in Geneva? This international client is looking for a QA manager to join the company. You will be responsible to maintain and manage the R&D site's Quality Assurance (QA) activities in compliance with GMPs, ensuring a constant state of regulatory compliance and quality services. Your responsibilities:- You will manage the development, implementation and maintenance of the Quality System.- You will review/approve the issuance of quality documents (SOP’s, specifications protocols, reports..)- You will manage deviations with the concerned functions, the corrective and preventive actions (CAPA) and participate to quality investigations- You will manage the Change Control process: review and evaluate change control requests- You will review and approve validation and qualification protocols and reports, including CSV- You will review and approve stability protocols, reports and batch records- You will participate to risk Analysis- You will manage annual quality training and training plan- You will manage suppliers, subcontractors, external audits and inspection from Regulatory Authorities. - Manage the Quality Assurance Manager AssistantYour profile: - You have a Bachelor, Master degree in Chemistry, Pharmacy, or Biochemistry- You have at least 7 years of experience in QA environment within Pharmaceutical or Biotechnology industry- You are fluent in English (both oral and written)- Extremely motivated, with rigorous work habits and problem-solving skills- Track record of successful inspection from regulatory authorities- Knowledge and experience of GLP is an asset
    Are you a QA specialist?Are you looking for a new challenge in the pharmaceutical industry in Geneva? This international client is looking for a QA manager to join the company. You will be responsible to maintain and manage the R&D site's Quality Assurance (QA) activities in compliance with GMPs, ensuring a constant state of regulatory compliance and quality services. Your responsibilities:- You will manage the development, implementation and maintenance of the Quality System.- You will review/approve the issuance of quality documents (SOP’s, specifications protocols, reports..)- You will manage deviations with the concerned functions, the corrective and preventive actions (CAPA) and participate to quality investigations- You will manage the Change Control process: review and evaluate change control requests- You will review and approve validation and qualification protocols and reports, including CSV- You will review and approve stability protocols, reports and batch records- You will participate to risk Analysis- You will manage annual quality training and training plan- You will manage suppliers, subcontractors, external audits and inspection from Regulatory Authorities. - Manage the Quality Assurance Manager AssistantYour profile: - You have a Bachelor, Master degree in Chemistry, Pharmacy, or Biochemistry- You have at least 7 years of experience in QA environment within Pharmaceutical or Biotechnology industry- You are fluent in English (both oral and written)- Extremely motivated, with rigorous work habits and problem-solving skills- Track record of successful inspection from regulatory authorities- Knowledge and experience of GLP is an asset
    • plan-les-ouates, genève
    • permanent
    Vous avez une certaine expérience dans le QMS dans le domaine des dispositifs médicaux ? Vous souhaitez continuer votre développement dans ce domaine ? Alors je vous invite à lire les quelques lignes ci-dessous!Pour l’un de nos clients, spécialisé dans les dispositifs médicaux et basé dans la région de Genève, nous recherchons un(e) Quality System Specialist pour un contrat à durée indéterminée.Vos tâches:SMQ: Vous êtes responsable du bon fonctionnement du Système de Management de la Qualité (SMQ), en développant des processus et en rédigeant des procédures et pour supporter le développement et l’amélioration du SMQ ; Vous organisez, contrôlez et améliorez la qualité de tous les processus du groupe en ligne avec les exigences réglementaires applicables (incluant au minimum : ISO 13485, 21 CFR Part 820, MDD 93-42-EEC, MDR 2017/745) Gestion de la Documentation : Vous assurez l’organisation et le contrôle de la documentation ainsi que la validation des documents (SOP, WI, Forms, Labels, IFUs, Surgical techniques…) ;NC : Vous assurez le respect du processus de gestion des NC et la validation des NC ;CAPA: Vous participez au processus de gestion des CAPA ;Audits Internes, Externes et Fournisseurs : Vous participez à la réalisation des audits internes et externesFormations : Vous effectuez les formations liées à la qualité comme le QMS, les GDP, et autres sujets spécifiques ;Réglementaire : Vous supportez la préparation et la maintenance des dossiers d’enregistrement, vous participez à la veille réglementaireParticipation aux validations des systèmes informatisés Votre profil:5 ans d’expérience en qualité système, idéalement dans le domaine des Dispositifs médicauxExpérience en ISO13485 et idéalement dans le 21CFRpart820Bon niveau d’anglais écrit et oralRigoureux, organisé et bon communiquant Alors, cela vous a plu ? Postulez sans attendre!
    Vous avez une certaine expérience dans le QMS dans le domaine des dispositifs médicaux ? Vous souhaitez continuer votre développement dans ce domaine ? Alors je vous invite à lire les quelques lignes ci-dessous!Pour l’un de nos clients, spécialisé dans les dispositifs médicaux et basé dans la région de Genève, nous recherchons un(e) Quality System Specialist pour un contrat à durée indéterminée.Vos tâches:SMQ: Vous êtes responsable du bon fonctionnement du Système de Management de la Qualité (SMQ), en développant des processus et en rédigeant des procédures et pour supporter le développement et l’amélioration du SMQ ; Vous organisez, contrôlez et améliorez la qualité de tous les processus du groupe en ligne avec les exigences réglementaires applicables (incluant au minimum : ISO 13485, 21 CFR Part 820, MDD 93-42-EEC, MDR 2017/745) Gestion de la Documentation : Vous assurez l’organisation et le contrôle de la documentation ainsi que la validation des documents (SOP, WI, Forms, Labels, IFUs, Surgical techniques…) ;NC : Vous assurez le respect du processus de gestion des NC et la validation des NC ;CAPA: Vous participez au processus de gestion des CAPA ;Audits Internes, Externes et Fournisseurs : Vous participez à la réalisation des audits internes et externesFormations : Vous effectuez les formations liées à la qualité comme le QMS, les GDP, et autres sujets spécifiques ;Réglementaire : Vous supportez la préparation et la maintenance des dossiers d’enregistrement, vous participez à la veille réglementaireParticipation aux validations des systèmes informatisés Votre profil:5 ans d’expérience en qualité système, idéalement dans le domaine des Dispositifs médicauxExpérience en ISO13485 et idéalement dans le 21CFRpart820Bon niveau d’anglais écrit et oralRigoureux, organisé et bon communiquant Alors, cela vous a plu ? Postulez sans attendre!

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