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Commissioning & Qualification (C&Q) Lead
Expleo Technology Switzerland, Neuchâtel, Switzerland
Expleo Life Sciences Switzerland assist the industry in the realization of their projects through engineering services and project management, safety and security, compliance and performance and through a specific offer \"digital transformation\". We are looking for a : Commissioning & Qualification (C&Q) Lead As part of the creation of a new dry form building, the C&Q Lead has the overall management responsibility of the C&Q Firm who will be responsible for Design Qualification, Factory Acceptance Tests, Site Acceptance Tests, Commissioning, Qualification, Hand Over, and Close Out. Key Responsibilities The C&Q Lead will provide oversight of the site commissioning and qualification organization in support of capital projects. The incumbent in this role will lead and manage an experienced team of colleagues and contractors focused on commissioning and qualifying facilities, utilities, dry forms process equipment and Computerized System The individual oversees C&Q work activities of major complexity to ensure on time and within budget completion. Responsible for driving the commissioning and qualification activities of a new facility (incl. Utilities, equipment, CSV, ...) according to standards and regulatory requirements. Lead a team of colleagues and contractors to achieve C&Q objectives aligned with capital project milestones and site goals. Approval the C&Q Firm deliverables. Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies. Interface with multiple sites and departments (Engineering, Technical Services, MS&T, end user groups, QA, suppliers, Architectural / Engineering Contractor, Construction Management contractor, Asset Care Management contractor, and C&Q contractor) to accomplish predefined goals and to provide technical guidance including but not limited to facilities, utilities, building equipment, production dry forms equipment, automation, cleaning approach and Computerized System validation. Design and author the validation/qualification approach (plan), provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports. Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing. Lead/support the project team, coordinate the execution of C&Q of the project, prepare project schedules and provide presentations to senior management / stakeholders on project status. Lead/support the completion of complex investigations, initiate change controls (incl. assessing impact of the change) and managing corrective action plans associated with C&Q activities Lead/Support the implementation of structures, tools, and processes to actively manage C&Q activities. Participate when required during internal and external audits forwhich they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation Qualifications & Experience Minimum of 10 years of relevant pharmaceutical industry experience (with a focus on dry forms pharmaceutical application validation in a GMP environment). Minimum 10 years ‘experience in managing personnel and/or complex projects, including direct experience in managing different Commissioning/Qualification/Validation contractors and activities for large and complex projects. Strong problem-solving skills, strong verbal and written communication skills. Ability to work independently and to influence and work across organizational boundaries. Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required. Excellent command of English and preferably French language. Project and change management experience. Experience with Product Life Cycle Management. Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face to face interaction and response to audit questions. The successful C&Q Lead candidate should have around 10+ years of industry experience, with project experience including green and/or brownfield projects in the pharmaceutical dry forms industry. In general, the selected C&Q Lead will be directly collaborating with the rest of the project core team, project controls, and site validation teams to direct the implementation of the project. Experience with the similar project management process, documents, and deliverables is advantageous. While the capital project manager will remain responsible for seeking funding approvals within the team and overseeing the success of the project, the C&Q Lead will be responsible for executing required steps within the Stage Gate project management process and ensuring successful collaboration with the rest of the project team. Additionally, the C&Q Lead will be the key driver in developing and updating the C&Q project budget/estimate and schedule, especially in the design phase and into the construction and C&Q phases. Our positions are accessible to people with disabilities Neuchâ2000 Neuchâtel
Junior Mobile Developer - IOS (Swift) / Android (Kotlin)
Randstad (Schweiz) AG, Neuchatel, Switzerland
Junior Mobile Developer - IOS (Swift) / Android (Kotlin) Jobdescription For our client, an international company based in Neuchatel, we are looking for a Junior Mobile Developer - IOS (Swift) / Android (Kotlin) Your Profile:* Possess a Bachelor's or Master's degree in software engineering.* Have 2-3 years of experience in a software development environment.* Demonstrate outstanding proficiency in Swift and Kotlin* Fluent in both English and French, with proficiency in additional languages like German considered a bonus. Your Future Role :* Integrate quickly in the software development team and start working on customer-facing projects.* Take ownership and improve our recently re-launched mobile applications that already have an excellentNPS.* Participate in technical discussions together with the team involving other technologies.* Technical specification definition in direct collaboration with the technical Manager.* Write well-designed, documented, secure and testable code, keeping in mind the customer perspective. Sandra Roleira
Project Manager - Program F/H
Safran Timing Technologies SA, Neuchâtel, Switzerland
Project Manager - Program F/HJob Description Le ou la titulaire de ce poste aura la responsabilité de gérer des projets de Recherche et Développement pour les trois lignes de produits d'Orolia Switzerland (Industriel & Défense, Science et Spatial) en soutien du Directeur de la R&D selon les mandats qui lui seront confiés par le Directeur des Programmes. Responsabilités - Participation à l'établissement de l'offre initiale tant en terme technique, managérial et financier - Planification et suivi du projet - Gestion et animation de l'équipe projet - Gestion de la relation avec le client - Etablissement et suivi du planning - Suivi et maitrise des coûts selon les objectifs fixés - Support à la définition des ressources nécessaires (matérielles et humaines) en fonction des objectifs fixés par la direction du département et par le client - Suivi du respect des exigences clients tout au long du projet (compliance technique, contractuelle, managériale) - Préparation et animation des revues contractuelles - Participation à la génération de la documentation projet - Suivi de l'avancement projet en interne (gestion des actions et priorités) - Supervision et coordination des activités relatives aux différentes phases du projet (approvisionnement, design, fabrication, tests et validation) - Identification et gestion des risques - Reporting mensuel dans le cadre du suivi des affaires de la société Job Requirements Issu(e) d'un diplôme d'ingénieur ou universitaire en électronique / mécanique / physique, vous êtes fort d'une expérience avérée en tant de chef de Projet dans le domaine de développement de nouveaux produits (culture scientifique) - Maitrise des techniques et méthodes de gestion de projet - Capacités organisationnelles - Gestion de projet pluridisciplinaire - Excellente communication client - Adaptabilité, réactivité, disponibilité - Maitrise de la suite Office (MS Project, Word, Excel) Specificity of the job Emplacement : Neuchatelb(SUISSE)
Project Coordinator
Maffioli Emplois & Cie, Neuchâtel, Switzerland
Project Coordinator On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a Project Coordinator Vos tâches Competences The Project Coordinator is responsible for coordinating all aspects of the change management process and facilitating the Data Integrity Risk Assessment (DIRA) required for this project. Working with project teams, the incumbent identifies and facilitates resolution of issues to minimize impact on project plans.The Project Coordinator supports the Operational Site readiness Project manager in the development and continual improvement of project and program management competencies. 3. Duties and Responsibilities * Support the overall Program Lead and the Operational Site readiness Project manager in the development, direction, & implementation of the GPS Pharma Boudry Business Transformation strategy that will deliver Best in Class performance through a highly engaged workforce* Develop in partnership with Quality Assurance the Change Control Strategy for the project.* Draft and initiate Change Control(s) in Infinity upon approval of the Change Control Review Board.* Track action completion and deliverables using appropriate tools and escalate if required.* Work closely with quality, compliance, and support other departments to ensure compliance with industry regulations and quality standards.* Facilitate Data Integrity Risk Assessment supporting package Owners in this exercise.* Convene and lead meetings with stakeholders and team members to elaborate on assigned topics based on project schedule and project needs related to operational readiness* Lead team meetings and ensure that meeting agendas and minutes are issued in a timely manner.* Ensure action plan deliverables are captured in the overall integrated project schedule if any of those actions have dependencies with specific Project Milestones. Manage and lead cross-functional project and/or program teams.* Anticipate challenges and risks. Prepare, lead and execute proactive mitigation strategies to ensure optimal results.* Performs other tasks as assigned. Votre profil Skills/Knowledge Required * Strong understanding of GMP quality systems supporting document management and change controls* Strong organizational skills and ability to effectively manage assignments* Good communication skills, ability to work with multiple departments in high pressure urgent need scenarios* Advanced critical reasoning, negotiation, problem solving and decision-making skills and team facilitation skills* Advanced written and verbal communication skills* Ability to work independently and make decisions for routine tasks and minor issues simultaneously.* Drives continuous improvement and « out of the box » thinking* Good organization skills and priority management* Preferred experience with Risk Management Principles* Intermediate proficiency in MS Project and Microsoft Office Suite M. Dominique Bréa+41 32 720 20 30Grand-Rue 62000Neuchâtelhttps://www.maffioli.ch
Analyst, QC Microbiology
Maffioli Emplois & Cie, Neuchâtel, Switzerland
Analyst, QC Microbiology On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a Analyst, QC Microbiology Vos tâches Position Summary The QC Microbiology Analyst is part of the Microbiology team of the Quality Control department.The main responsibilities of the position include performing Environmental Monitoring in cleanrooms, waters, and compressed gases for routine monitoring and area qualification.The analyst will also perform and review microbiological tests on raw materials, manufactured drug products and stability samples and performing peer review of raw data.The analyst may also participate in projects related to laboratory safety or continuous improvement and participates to QC documentation changes.The QC Analyst carries out her/his activities in compliance, always, with laboratory procedures and safety rules (EHS) as well as good documentation and good manufacturing practices (GDP and GMP).The position will report to Sr. Manager QC Microbiology. Key Responsibilities Microbiological testing of raw materials and drug products according to incoming testing, release, and stability specifications.* Environmental monitoring of cleanrooms (microbiological and particles tests), compressed air, and waters (microbiological tests, TOC, conductivity, nitrates)* Microbiological testing of raw materials and drug products according to incoming testing, release, and stability specifications.* Support execution of method validation protocols* Execute Peer Review of analytical raw data generated in the Microbiology Laboratory.* Support release of culture Media (growth promotion testing) and material used in Microbiology laboratory.* Preparation of microorganism's identifications. Support QC Microbiology activities. * Support maintenance/calibration of equipment and keeps relationship with suppliers.* Support training of other members of Quality Control or other departments* Perform general laboratory tasks (sample management, waste disposal management, cleanings, etc.).* Support supply management of consumables, including purchase requisitions.* Create and update of procedures, work instructions and other QC documents.* Participation in projects and implementation of continuous improvement actions in the laboratory.* Participate and create presentations at QC team meetings.* Respect 5S principles and propose 5S improvements.* Other responsibility assigned by the laboratory management.Promotes safe practices and behaviors.* Report immediately incidents to Environmental Health and Safety department, participate in investigations and identify measures to prevent similar accidents in the future.* Demonstrate Bristol Myers Squibb values. Votre profil Qualifications & Experience Education and Experience* Federal Certificate of Capacity as Laboratory Technician or similar education.* At least 1 year of work experience in a GMP environment or regulated industry.* Experience with microbiological testing according to compendial harmonized methods.* Good knowledge and ability to apply GDP and GMP rules.Required Competencies: Knowledge, Skills, and Abilities* Knowledge on experience of environmental and water and compressed air monitoring.* Knowledge of good microbiological practices and contamination control concepts.* Knowledge of regulatory requirements related to microbiological testing and environmental monitoring.* Good organizational skills and good multi-tasking ability; ability to set and focus on priorities.* Strong attention to details* Ability to work independently and collaboratively within a team.* Knowledge of laboratory safety rules.* Ability to write business and technical documents (good technical writing skills).* Capable of independent problem-solving; informs management as appropriate.* Computer proficiency (Windows and MS Office) and ability to use a LIMS.* Fluency in French and professional command of English (oral and written)* Ability to communicate effectively with peers (QC members, management, other departments).* Knowledge of the LEAN and 5S concepts and methodologies.* Flexible, able to adapt to change.* Able to stand for several hours, lift boxes about 24 kg or reach areas of 2 meters. Langues Fluency in French and professional command of English (oral and written) M. Dominique Bréa+41 32 720 20 30Grand-Rue 62000Neuchâtelhttps://www.maffioli.ch
Specialist QC Analytical Technical Support
Maffioli Emplois & Cie, Neuchâtel, Switzerland
Specialist QC Analytical Technical Support On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a Specialist QC Analytical Technical Support Vos tâches Position Summary In this role you will perform super user activities for the laboratory computerized systems, including Master Data Management activities, and associated GMP document updates. This position will act as a Super User providing support and training to End-Users of the QC laboratories as well as supporting investigations and resolution of issues. In addition, this position will support activities related to acquisition and qualification of new equipment, investigation and troubleshooting of analytical and equipment issues as well as introduction of new products to the QC laboratories. The Specialist will report to the Sr. Manager QC Analytical Tech Support. Key Responsibilities Super user of laboratory computerized systems: Performs master data management activities in computerized systems (e.g Empower, Dissolution Workstation, Tiamo, etc.), including new methods set up. Writes and executes verification protocol for custom calculations. Performs audit trail reviews and assures adherence to data integrity principles. Assists QC End Users with software issues. Provide end user training and on-the-job training for new employees where required. Updates and reviews associated GMP documents and procedures. Support change controls for QC software. Supports risk assessments. Equipment lifecycle activities. Supports acquisition and qualification of new analytical equipment. Performs feasibility experimental work as needed. Supports decommissioning of analytical equipment. Supports laboratory investigations in case of equipment-related deviations. Supports End-User with equipment troubleshooting. Deviation and Laboratory Investigation Support Supports system-related deviations. Supports laboratory investigations associated to equipment deviation. Supports with corrective and preventive actions definition. Promotes safe practices and behaviors Reports immediately incidents to Environmental Health and Safety department, participate in investigations and identify measures to prevent similar accidents in the future. Demonstrate Bristol Myers Squibb values. Votre profil Qualifications & Experience Education and Experience Federal Certificate of Capacity as Laboratory Technician or BS degree in Life Science, Chemistry, or relevant scientific discipline or equivalent combination of education, training and experience. Minimum 4 years relevant work experience required, preferable in a regulated pharmaceutical environment. Scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques). Previous experience of laboratory equipment qualification is preferable. Required Competencies: Knowledge, Skills, and Abilities Good scientific knowledge of chromatography techniques (HPLC, UPLC, GC), dissolution, Karl Fischer, and spectroscopic techniques. Exceptional knowledge of LIMS and Empower applications. Advanced knowledge and interpretation of cGMP, ISO, FDA, MHRA and Pharmacopeia requirements, and good documentation practices. Advanced knowledge of Data Integrity principles, familiar with audit trail review requirements. General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook) Effective verbal communication skills, ability to interact with different levels of the organization and departments. Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports). Proven analytical, problem-solving, and continuous improvement skills. Proven time management skills and a strong attention to detail. Ability to work independently and compliantly. Physical ability to perform tasks that may require prolonged standing, sitting, and other activities necessary to perform job duties. Fluent in English or French and professional command of the second language (written and verbal). Langues Fluent in English or French and professional command of the second language (written and verbal). M. Dominique Bréa+41 32 720 20 30Grand-Rue 62000Neuchâtelhttps://www.maffioli.ch
HR Project Manager Temp M/W/D
Michael Page, Neuchâtel
- Develop and optimize HR processes. - Conduct reviews and updates of company regulations and internal documents. - Enhance workplace tools, such as competency management systems. - Lead the implementation of new HR software solutions.Has at least 10 years of experience as an HR expert.Fluent French and EnglishPossesses a proven track record in HR project development and management.Holds a professional HR certification.Demonstrates a proactive approach to team engagement and cultural participation.
Technical Sales Manager
Careerplus, Neuchâtel, Switzerland
Technical Sales Manager Cherchez-vous à dynamiser votre carrière dans la vente ? Rejoignez un leader en technologies de pointe et faites la différence !Notre partenaire est un acteur majeur dans le domaine de la technologie de précision. Cette entreprise se distingue par son innovation constante et son engagement envers la qualité et la fiabilité. Elle offre un environnement de travail stimulant, axé sur la technologie de pointe et l'excellence. Actuellement, elle cherche un-e Technical Sales Manager pour renforcer son équipe. Le-la candidat-e retenu-e sera chargé-e de développer de nouvelles opportunités commerciales et de maintenir des relations de qualité avec les clients. Vos activités chez votre futur employeur Vous identifierez et acquerrez de nouveaux clients dans le secteur industriel Vous organiserez et effectuerez des visites clients, en Suisse et à l'international, pour présenter des produits innovants Vous travaillerez de manière autonome, en planifiant et en exécutant vos stratégies de vente Vous collaborerez étroitement avec les équipes techniques pour assurer la mise en oeuvre des projets Vous utiliserez votre expertise technique pour comprendre les besoins de vos clients et les conseiller efficacement Vos atouts pour votre futur employeur Vous possédez une solide formation en électronique (type ingénieur-e) Vous témoignez d'une expérience avérée dans la vente technique, idéalement dans le secteur aérospatial ou un domaine connexe Vous maîtrisez l'anglais, essentiel pour les interactions internationales Vous êtes familier-ère avec les systèmes informatiques et avez une affinité pour les technologies de pointe Votre capacité à communiquer efficacement et à établir des relations de confiance est primordiale Vous pourrez également profiter des avantages suivants 6 semaines de vacances pour les
Customer Care Manager
BM-EMPLOI SA, Neuchâtel
Votre profil: Vous disposez de 5 ans d’expérience dans un poste avec management Première expérience dans un service client réussie, 3 à 5 ans Vous possédez d’excellentes connaissances en Français, Allemand et Anglais tant à l’oral qu’à l’écritVous disposez d’une forte orientation clients, êtes diplomate et proactif Vous êtes disposé à voyager à l’étranger (10%) ainsi que sur l’ensemble du territoire Vos tâches: Encadrer et former l’équipe Customer Care Gérer la communication du service en Suisse et à l’étranger Mise en place de projets d’amélioration continue Analyser des retours clients Analyser et valider des gestes commerciaux Support technique de première ligne
Customer Care
BM-EMPLOI SA, Neuchâtel
Votre profil: Formation commerciale avec 3 ans d'expérience dans un poste similaire dans une société du domaine du luxe Vous aimez le contact et avez un excellent sens relationnel Vous êtes une personne consciencieuse, précise et organisée Vous possédez de bonnes connaissances écrites et orales de l'anglais et de l'allemand Vos tâches: La gestion des relations, tant avec les partenaires internes qu'externes en termes de service clientèle internationale et des activités commerciales de la marqueLe suivi complet des commandes, de la réception à l'envoi des produits en toute autonomie (facturation, établissements des documents douaniers, organisation des transports et documents d'exportation)Un point de contact dans le suivi des disponibilités de produits