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Trouvez votre emploi avec Axepta SA

Executive Assistant

Axepta SA
Suisse, Vaud, Morges - Axepta SA
Pharmaceutique
Réception/Secrétariat/Services généraux

Axepta is looking for an executive assistant for one of its clients, an international company active in the pharmaceutical sector. DUTIES AND RESPONSABILITIES  - Assist the Executive Vice President and Head of Global Technical Operations with daily operational tasks and specific projects as needed.  - Manage the Executive's calendar, coordinate travel arrangements and conferences, schedule appointments, and arrange meetings.  - Organize offsite meetings and events for the Global Technical Operations team.  - Review and analyze incoming emails, letters, agendas, and memos, and distribute important information to the appropriate recipients promptly. Prepare reports, gather and assess data to support executive decision-making. - Create presentations and other documents to facilitate executive communication.  - Support the Tech Ops management team with administrative tasks and project work as required.  - Coordinate team meetings, video conferences, agendas, logistics, minutes, follow-up actions, timing, locations, attendees, travel, and facilities. Generate reports to monitor expenses, invoices, and cost center allocations.  - Process purchase requests, track purchase orders and invoices.  - Undertake special projects assigned by the Executive. Represent the Executive in meetings with special interest groups or individuals.  - Stay informed by participating in professional development seminars and workshops.  - Uphold a strong culture of business ethics and integrity. Handle confidential information with discretion.  - Adhere to legal requirements, compliance standards, and company policies. REQUIREMENTS: We are looking for a person with very good communication skills (verbal and written) with a strong attention to detail is essential.  A very good command of MS Office inculding presentations on PowerPoint. Experience scheduling travel arrangements for management.  The person should be very well organized, flexible and ready to manage the administrative challenges of supporting a busy group of diverse people and programs. We are looking for someone that possess the ability to interact with staff (at all levels) in a fast paced environment. Keep her capabilites under pressure with a high level of professionalism and confidentiality. Flexibily and proactive skills are needed.  

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Nouveau!
23/05/2024

QA Manager Biologics

Axepta SA
Suisse, Vaud, Vaud - Axepta SA
Pharmaceutique
Autre

  Our client based in the canton of Vaud is currently seeking a Biologics QA Manager to strengthen their team following an increase in activity. This assignment will be for a minimum duration of 6 months due to the company's growth. This person will oversee the quality of clinical and commercial manufacturing and testing activities at CMOs for assigned products (drug substance and drug product). They facilitate the transfer of biologic compounds from development to commercialization, collaborating closely with internal and external stakeholders.   Yours Responsibilities   - Serve as the QA expert for assigned biological products. - Oversee the quality of assigned Clinical and Commercial CMOs, including compliance and performance monitoring. - Manage quality throughout the lifecycle of assigned projects, from development and process/method validation/transfer to registration and commercialization. - Make batch disposition decisions after thoroughly reviewing batch documentation. - Collaborate with the other departments for batch confirmation and certification in relevant markets. - Maintain and control Product Batch records and databases. - Manage and approve deviations, OOS, investigations, CAPAs, and Change Controls promptly. - Conduct quality reviews of stability data for products under their scope. - Establish and maintain Quality and Technical Agreements with assigned Clinical and Commercial CMOs. - Support the maintenance of the Quality Management System, focusing on biologics-related SOPs. - Perform internal and external audits as a qualified auditor, review and approve responses, and ensure CAPA follow-up with concerned CMOs. - Provide QA support to the RA-CMC group for regulatory submissions and follow-ups. - Implement Quality Risk Management to identify and mitigate risks related to product quality, safety, and GMP compliance of the assigned CMO. - Interpret and implement GMP, general regulatory requirements, and Quality systems regulations in manufacturing.   Your Qualifications:   - Master's degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering). - Minimum 5 years of experience in Quality Operations for pharmaceuticals. - Expertise in manufacturing and testing biotechnology products. - Experience overseeing Contractor Quality. - In-depth knowledge of cGMP and regulatory requirements - Proven ability to write technical documents, such as APQR. - Track record in project management as a project team member, able to contribute to multiple ongoing projects. - Knowledge of technical transfer requirements for Biologics. - Strong interpersonal skills. - Excellent verbal and written communication skills, with a well-structured communication and presentation ability. - Commitment to continuous improvement. - Results-oriented, with skills in negotiation, empathy, diplomacy, and common sense. - Fluent in written and spoken English (company language). - Willing to travel up to 20%.

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Nouveau!
23/05/2024

Responsable maintenance ligne

Axepta SA
Suisse, Vaud, Lausanne - Axepta SA
Médical/Dispositif Médical
Autre

Pour notre client, leader international dans son domaine (medical devices), nous recherchons un Responsable de ligne - maintenance.     Tâches & responsabilités - Définir, organiser et réaliser le programme de maintenance préventive et l'adapter sur la base d'inspections régulières - Préparer les interventions planifiées pour le pôle de techniciens de dépannage - Analyser les pannes et suivre les indicateurs de performance de sa ligne - Participer aux rituels de production & de maintenance - Contrôler toute intervention technique effectuée par des tiers du point de vue de la qualité du travail ainsi que la bonne documentation de l'intervention - Dans le cadre de l'OPEX, participer au déploiement de l'auto-maintenance sur sa ligne - Former les opérateurs à l'auto-maintenance et les techniciens de maintenance aux interventions sur les équipements - Supporter les équipes de dépannage en cas de pannes, en vue de remettre l'installation en état et en conformité GMP - Participer aux projets d'amélioration des équipements Compétences professionnelles - CFC de mécanicien-électricien avec une formation complémentaire en maintenance, idéalement au bénéfice d'un brevet fédéral d'agent de maintenance, d'une maîtrise fédérale ou diplômes équivalents - Plus de 5 ans d'expérience en maintenance d'équipements de production, idéalement dans le domaine pharma et/ou alimentaire et/ou chimique - Bonnes connaissances en mécanique, pneumatique, hydraulique, automation et électricité - Connaissances opérationnelles TPM / LEAN & 5S - Connaissances d'Excel et SAP sont un atout et idéalement de TrackWise   Pour plus d'information : adrien.menard@axepta.com  

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Nouveau!
22/05/2024

Supply Planner

Axepta SA
Suisse, Genève, Geneve - Axepta SA
Médical/Dispositif Médical
Autre

For our client in medical devices, we are looking for a Supply planning   Responsibilities:   - Collect the Finished Products needs from the markets based on real orders and sales forecasts; - Define and propose stock coverage strategies in Germany; - Build delivery plans accordingly to our internal customer, aligned and in close collaboration with the Demand Planners from the Regions; - Ensure adequation between demand and supply forecast plannings; - Develop, maintain and optimize the supply planning processes   Packaging planning - Establish and communicate priorities to our secondary packaging sub-contractor;   - Ensure proper SAP flow of products from the packaging of our products to their delivery to our customer; - Ensure regular inventory counts and possible stock corrections in the SAP sub- contractor stock   SAP & Master Data - Products and check their adequation with the SAP Master - Data at sub-contractor and customer.   Support to Quality and ComPliance processes - Support investigation of any incident or complaint that may arise in the area   Metrics management - Define, monitor and analyze Key Performance lndicators (KPl's) and Metrics to drive continuous improvement processes within the area of responsibility   Profile : - Minimum 5-10 years experience in a similar position - Proven experience in SAP: forecasting, inbound/outbound processes, scheduling agreements, vendor stock, master data. - Excel fluent (data analysis). - Reporting and analytical skills. - Knowledge of lso and preferably GMP rules as applicable to medical devices - Good understanding of main processes supporting the supply chain management from vendor selection to product shipment. - Fluent in French.

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Nouveau!
22/05/2024
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