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87 Ergebnisse

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87 Ergebnisse

    Referenznummer: 794022/1

    Application Specialist (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • System Administration; manage and maintain system access. Develop processes to monitor and maintain system
    • Support project teams in set up of projects and user access
    • Supports with troubleshooting and resolution of issues
    • Solicits feedback from end users to understand needs, application use, and potential improvements. Training, guidance and support to end users in system use and functionality
    • Drafts requirements, liaises with development team and assists with development and testing of new features
    • Supports the maintenance and updating of system documentation and procedures
    • Provides reports, data extractions and status updates as requested by management
    Online seit: Tue Nov 19 15:40:53 CET 2024
    Referenznummer: 793850/1

    CQV Engineer (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • The CQV Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others
    • The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ). Prepare validation documents
    • Execution of IQ/OQ and PQ for equipment, systems and utilities
    • Write reports of completed validation activities
    • Work to identify efficiencies in the validation program approach
    • Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation
    • Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s. Writing and/or revising procedures applicable to the Engineering activities
    • Support the Engineering group to prepare the validation, requalification, and maintenance program
    • Perform other duties as assigned
    Online seit: Mon Nov 18 10:12:58 CET 2024
    Referenznummer: 793838/1

    Medical Manager / Medical Scientific Liaison Manager – Rare Disease (m/f/d)

    Freelance/temporary employment for a project
    Zug
    • Responsible for the development of national medical strategy in the area of rare disease / Proactive and reactive provision of relevant medical, indication and product specific information to relevant stakeholders, brand team, physicians, nurses, pharmacists, and other relevant HCPs 
    • Create, communicate, and implement a strategic publication plan in coordination with the global publication strategy 
    • Build strong, sustainable partnerships with relevant partners (physicians, nurses, pharmacists and other HCPs) and a thought leader network 
    • Engage with professional societies to implement medical scientific partnerships 
    • Medical and scientific representative of the company at national and international congresses, symposia, investigator meetings and similar events
    • Conceptualize, budget, initiate and follow up on medical projects / Act as an Expert in rare disease and propose actively
    • Medical expertise in the x-functional collaboration (local brand team)
    • Advising internal stakeholders on product-specific and other medical requests / Ensure proper documentation of relevant medical insights into designated internal documentation tools and prepare medical statements and drug information
    • Close support of the specialist departments (Regulatory, Market Access, PV) and of the release promotional and medical information material
    • Plan, design and execute medical education events for physicians, nurses, etc. (e.g., advisory boards, round table meetings, symposia)
    Online seit: Fri Nov 15 16:16:11 CET 2024
    Referenznummer: 793445/1

    Document Controller (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • Review the punch lists for the missing or incorrect documentation for the Vendor Turn-Over Packages
    • (VTOP) and the Construction Turn-Over Packages (CTOP) and drive the Vendors/Contractors to close the identified issues
    • Review the punch lists for the missing or incorrect documentation for the Vendor Turn-Over Packages 
    Online seit: Fri Nov 15 15:37:16 CET 2024
    Referenznummer: 793638/1

    Quality Project Manager (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Acts as TRD excipient portfolio manager. Interacts and collaborates with internal and external stakeholders, customers and/or suppliers, according to specific area of responsibility
    • Maintains TRD excipient portfolio regarding supplier approval
    • Ensures change control management of excipient related matters notified by suppliers or triggered internally. Supports project teams in case of excipient-related request
    • Handling of change actions and CAPAs, related to excipient involving multiple project users in TRD about supplier or product specifications. Guides project teams through new excipient implementation operations
    • Acts as line unit representative to TRD Third Party QA organization with respect to TRD excipient portfolio and ensures that own deliverables are met
    • Acts as line unit representative and SME for interactions within TRD and with NTO excipient counterparts on local sites when needed
    • Supports PHAD Excipient Supply and Demand planning coordinators. Acts as key expert for new excipient/supplier implementation in TRD portfolio
    • Coordinates activities linked to transfer of excipient ownership from commercial site back to TRD in case of discontinuation
    • Maintains effective information channel with all involved parties. Communicates issues to involved partners. Ensures compliance to Company and other relevant regulations
    • Shows positive work ethics and influences others. Proposes and implements ideas for continuous process improvement also outside area of expertise/ organization.
    Online seit: Fri Nov 15 14:22:48 CET 2024
    Referenznummer: 793457/1

    Scientist Analytical Chemistry (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Plan, interpret and report results of scientific experiments for timely supply of drug substances (DS) and drug products (DP)
    • Write & review analytical documents (e.g Analytical methods, Specifications, Validation reports, Stability reports, Batch records for stability and release testing) and align the corresponding activities within a global project team
    • Manage interactions with internal and external stakeholders, including outsourced activities to CROs by providing scientific and technical guidance whenever necessary
    • Proactively identify scientific, technological and GMP challenges, propose creative solutions and communicate key issues to the Analytical Project Leader or respective technical project team
    • Work according to appropriate SOPs, GMP, Quality Directives, Health and Safety & internal Company guidelines
    • Provide valuable input to the analytical CMC documents and support regulatory submissions
    • Drive, lead, and manage analytical activities including impurity profiling related to the analytical development of RLTs compounds (e. g. method development, validation, stability, and release testing)
    • Provide scientific guidance to the cross-functional and global project teams and thereby scientifically driving our exciting RLT portfolio
    • Display a collaborative and inspired attitude within project teams and our stakeholders and partners is key.
    Online seit: Thu Nov 14 12:12:19 CET 2024
    Referenznummer: 792565/1

    Turnover Coordinator (m/f/d)

    Freelance/temporary employment for a project
    Stein, Aargau
    • Assists in the development of the turnover process including roles and responsibilities, workflows and interfaces
    • Supports in the coordination of the turnover scope with Engineering, Construction and CQV
    • Preparation and support of system boundaries for process and non-process systems
    • Management and direction of Mechanical Completions Walkdowns, including capture of punch items
    • Punchlist Management
    • Preparation of Construction Turnover Packages (CTOP)
    • Processing and preparation of mechanical completion certificates 
    • Receipt and processing of construction dossiers from contractors
    Online seit: Mon Nov 11 12:12:27 CET 2024
    Referenznummer: 792560/1

    Sr. Technical Program Lead (m/f/d)

    Freelance/temporary employment for a project
    Stein, Aargau
    • Coordinate and track the technical specification and standards creation and updates associated to the targeted areas for improvement, this includes guidance documents, procedures and policy where necessary
    • Collaborate with internal SMEs and standard owners to progress the technical specification and standard review, ensuring alignment with the site's requirements and industry best practices
    • Supports project teams in resolving technical or specification-related issues by facilitating with technical competence across multiple disciplines, in addition to coordinating and communicating
    • Provide regular ‘Time, Cost, Quality’ updates for the program to SteerCo and C-level as requested
    • Assists in the development of the turnover process including roles and responsibilities, workflows and interfaces
    • Supports in the coordination of the turnover scope with Engineering, Construction and CQV
    • Preparation and support of system boundaries for process and non-process systems
    • Management and direction of Mechanical Completions Walkdowns, including capture of punch items Punchlist Management
    • Preparation of Construction Turnover Packages (CTOP)
    • Processing and preparation of mechanical completion certificates
    Online seit: Mon Nov 11 12:04:57 CET 2024
    Referenznummer: 792558/1

    Automation Engineer - HVAC (m/f/d)

    Freelance/temporary employment for a project
    Stein, Aargau
    • Provide design support for the generation and configuration of the DeltaV system configuration for the following utility systems which are monitored and controlled by the DeltaV DCS
    • Heating Ventilation and Air Conditioning for the classified and non-classified areas within the site manufacturing and utility areas
    • Environmental Monitoring System consisting of room monitoring conditions including differential pressure, humidity and temperature parameters
    • Air Lock Control Systems for the personal and material air lock controls to the clean rooms in the manufacturing areas
    • Review and approve Automation Requirements, Design, Test, Qualification and Validation documentation
    • Provide guidance and technical direction to the external System Integrator for the generation and testing of the DeltaV DCS software configuration
    • Support software FATs and SATs by approving documents and witnessing on behalf of Lonza as the Lonza Automation Representative
    • Support the integrated commissioning of the DeltaV system software, hardware and interfaces to the HVAC and associated systems listed above
    • Support the reliable operation of the HVAC control systems by providing hands on support to trouble shoot control system software and hardware issues
    • Support the overall Dolphin Project Team to collate supporting information to allow timely decisions to be made that will minimize cost, timeline and quality impact on the Project
    Online seit: Mon Nov 11 12:02:20 CET 2024
    Referenznummer: 792545/1

    Site Commissioning Engineer (m/f/d)

    Freelance/temporary employment for a project
    Stein, Aargau
    • Check on contractors schedule and track site progress on all systems i.e. Mech, Electrical, HVAC, Automation, CSA
    • Reporting to the building Technical PM, giving daily updates on status of construction commissioning progress
    • Support/accompaniment of 3D coordination, resolution of collisions, adjustments, etc.
    • Supervise contractor walkdowns for systems and utilities.
    • Track status of Document completion like CTOPs
    Online seit: Fri Nov 08 16:31:26 CET 2024

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    Referenznummer: 791909/1

    Project Controls Manager (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • Support the GE Project Managers on all project controls matters through final initiation, execution and close out phases
    • Direct and support project control team members (planners and cost engineers) to ensure project controls tools and processes are in place
    • Monthly validation and consolidation of commercial reporting of the CAPEX projects (e.g. Scope, Spend, Cost and Schedule, Risk, Forecasting, etc.)
    • Be the diplomatic lead to larger groups of cross functional project team members, gaining consensus and garnering support for the path forward on commercial topics
    • Support and Collaborate with GE PMO department to ensure that reporting processes are implemented and timelines are adhered to for the Capex Portfolio reporting
    • Manage and Collaborate with GE Functions and related Stakeholders, ensuring capex funding, controlling and forecasting is aligned
    • Proactively contribute to the implementation, delivery and development of first in class project controls systems and tools
    • Participate in delivery team and functional team meetings and workshops as required
    • Responds to ad hoc requests for data, data analysis, and presentation materials
    • Provides support to the project controls functional group as and when required
    Online seit: Thu Nov 07 15:24:01 CET 2024
    Referenznummer: 791720/1

    CQV Execution Engineer (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • Includes, but not limited to, execution of the following activities for the relevant systems in accordance with project procedures/guidelines.
    • System Boundary development and approval
    • Design Qualification preparation, execution and approval. Includes release for IQ
    • GMP-RA’s
    • Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality
    • Installation Qualification preparation, execution and approval. Includes release for OQ
    • Operational Qualification preparation, execution and approval. Includes release to OPS
    • Provide support in execution of Design Qualification for other direct impact systems
    • Provide support in the implementation of the Installation Commissioning process in accordance with project procedures/guidelines
    Online seit: Wed Nov 06 15:35:08 CET 2024
    Referenznummer: 791725/1

    Digital Biomarker - Biomedical Engineer (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Support the digital biomarker evidence generation activities with data analysis and statistical expertise 
    • Perform sensor time-series analysis to improve and validate digital biomarker algorithms 
    • Support the organization and documentation of data coming from various sources and systems to facilitate the data analysis efforts 
    • Be responsible for a work package: break down a business question into planned work, following up of work in progress, risk assessment, communicating on progress and results, reading literature, writing reports and publications 
    • Contribute to development and maintenance of sensor data processing pipelines 
    • Contribute to analytical validation analyses
    Online seit: Wed Nov 06 14:44:23 CET 2024
    Referenznummer: 791734/1

    Digital Biomarker - Data Scientist (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Analyze clinical and digital biomarker data from various studies to develop and improve our digital biomarker solutions
    • Support the digital biomarker evidence generation activities with statistical modeling and analysis expertise
    • Be responsible for a work package: break down a business question into planned work, following up of work in progress, risk assessment, communicating on progress and results, reading literature, writing reports and publications 
    • Contribute to development and maintenance of statistical analysis pipelines
    Online seit: Wed Nov 06 14:42:27 CET 2024
    Referenznummer: 791497/1

    Construction Manager (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • Coordinate service providers, suppliers, and material flows
    • Manage owned works and coordinate with the EPCM company
    • Lead external planning teams and construction companies
    • Ensure smooth construction workflow and site organization
    • Ensure compliance with planning specifications, regulations and standards
    • Coordinate with other Construction Managers for project impact reviews
    • Conduct technical and commercial negotiations with suppliers
    • Coordinate equipment logistics and installation with suppliers and EPCM
    • Continuously improve Construction Management and Health & Safety Plans
    • Generate weekly reports and ensure project objectives (cost, deadlines, quality, safety) are met
    Online seit: Tue Nov 05 16:49:57 CET 2024
    Referenznummer: 791396/1

    Safety Officer Utilities Operations (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • Lead the work permit process, ensuring that all tasks are authorized and compliant with safety protocols before initiation
    • Conduct thorough risk evaluations, identifying and mitigating potential hazards in line with industry standards
    • Issue work permits following risk assessments, ensuring compliance with stringent safety requirements
    • Conduct regular, unannounced inspections of work areas to ensure ongoing adherence to safety measures
    • Approve workspaces post-task completion, ensuring they meet safety standards before re-approval for use
    • Maintain strict compliance with both internal safety guidelines and external regulatory requirements
    • Work closely with cross-functional teams to proactively manage safety risks, reporting on safety performance and suggesting improvements
    • Provide guidance and training to staff on best safety practices, reinforcing a safety-first mindset
    Online seit: Tue Nov 05 14:18:37 CET 2024
    Referenznummer: 791216/1

    Communications Specialist (m/f/d)

    Freelance/temporary employment for a project
    Bern
    • Managing and executing Communications activities for the site to support business objectives
    • Collaborates with business leaders, Site Leadership Team and project teams on development and implementation of external, digital and internal communications activities
    • Oversees and manages content of internal communications vehicles in area of responsibility: incl. intranet, organizations announcements, newsletters, Now app 
    • Manages content of external and digital communications vehicles in area of responsibility: incl. website and social media
    • Manages corporate messaging and ensures communications are aligned with the company’s global brand positioning
    • Develops and executes internal and external communications to ensure understanding, engagement and Company reputation
    • May also be responsible for project communications and special events
    • Participates in global communication projects; plan, coordinate and execute locally 
    • In addition, the individual in this role also serves as the Communications Business Partner for the organization, providing support for a variety of communications, including internal and external needs
    Online seit: Thu Oct 31 15:36:48 CET 2024
    Referenznummer: 790856/1

    Specialist Quality Assurance (m/f/d)

    Freelance/temporary employment for a project
    Lucerne
    • Review and release of incoming label stock
    • Review, and release of clinical finished goods, including review of the printed and applied label
    • GMP review of the batch record and review of the regulatory filings and the final release
    • Collaborate closely with our internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations,). 
    • Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP). This job requires a high sense of accuracy and very good time management skills which essential to ensure timely supply of the clinical drugs to patients. Prompt, professional and precise communication to local and global stakeholders is key.
    • Logbook reviews
    • Support in Quality Walkdowns, GEMBA walks and/or Walkthrough Audits of GMP areas/on the shop floor to sustain continuous improvements efforts, ensure quality compliance and/or identify potential area of improvements
    Online seit: Wed Oct 30 14:12:40 CET 2024
    Referenznummer: 789765/1

    Batch Record Reviewer (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais
    • Review executed electronic Batch Records, including cleaning logs, production documentation, temperature reports and test procedures
    • Clarify comments and discrepancies in Batch Records with the operations team and evaluate them with the QA Manager
    • Initiate and support the investigation of deviations and observations related to Batch Record reviews
    • Assist in the initiation of Change Requests (CRs) and Temporary Change Requests (TCRs)
    • Prepare documentation packages to support fast and efficient product release by QA
    Online seit: Thu Oct 24 13:31:22 CEST 2024
    Referenznummer: 789589/1

    Technical Project Engineer (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais, Switzerland
    • Represent the Project Engineering Team from the design phase through project handover, including procurement, construction, commissioning, and qualification
    • Serve as the primary contact between internal stakeholders (Operations, EHS, Plant Engineering) and external companies (engineering contractors, vendors)
    • Review and comment on engineering documents (P&IDs, data sheets, specifications) and participate in 3D model reviews
    • Ensure compliance with internal standards and specifications, especially in mechanical, quality, and EHS areas
    • Coordinate project schedules and budgets to ensure timely and cost-effective delivery
    • Review and approve technical aspects of purchase requests, purchase orders, change requests, and invoices
    • Participate in safety risk analyses (HAZOP) and implement mechanical discipline mitigation actions
    • Attend and contribute to FATs and SATs for assigned units, and oversee construction activities
    • Review and approve commissioning and qualification documentation, providing technical support through these phases until project handover to Operations
    Online seit: Thu Oct 24 13:27:22 CEST 2024
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