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89 Ergebnisse

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89 Ergebnisse

    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
    Referenznummer: 789322/1

    Digital Analyst (m/f/d)

    Freelance/temporary employment for a project
    Basel
    • Responsible for being the Product Owner of Analytic Platform
    • Assemble appropriate data to monitor key performance indicators 
    • Offer optimal digital experience to internal users
    • Analyze and optimize the usability of digital systems using app and web analytics tools
    • Drive business insights through data modeling and machine learning techniques using Python/R and SQL
    • Utilize data visualization tools such as Power BI, Tableau, ETL tools such as Prefect, Apache Airflow and AWS Glue
    Online seit: Tue Oct 22 11:01:41 CEST 2024
    Referenznummer: 788382/1

    Material Planner (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais, Swittzerland
    • Manage material planning and create VSF for independent requirements
    • Convert purchase requisitions to purchase orders
    • Maintain purchase orders according to supplier confirmation
    • Oversee release and contact QA for prioritization
    • Manage master data
    • Create, maintain, and delete material master data parameters
    • Inventory management
    • Process improvement
    • Support global and local initiatives
    Online seit: Fri Oct 18 13:57:14 CEST 2024
    Referenznummer: 788954/1

    Lab Assistant (m/f/d)

    Freelance/temporary employment for a project
    Zug
    • Manages, oversees, and executes the following in their assigned BSL1 &; BSL2
    • Regular cleaning of the BSL1 & BSL2 laboratories according to the hygiene plan
    • Waste management including collection and disposal
    • Lab coat management including adequate supply, collection and cleaning
    • Operation and monitoring of dishwasher, drying furnace and autoclaves
    • Maintaining stock of common lab consumables
    • Pipettes calibration support
    • Participates in the on-call services for CTU excursion
    • Dry ice area cleaning
    Online seit: Fri Oct 18 13:48:09 CEST 2024
    Referenznummer: 788959/1

    Lab Supervisor (m/f/d)

    Freelance/temporary employment for a project
    Zug
    • Manages, oversees, and authorizes the use of designated laboratory areas with regard to general lab operations (orientation, use, access, general supply replenishment, equipment, cleaning, & maintenance), regulatory compliance (documentation, temperature monitoring) and general safety operations
    • Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact user’s supervisor if necessary. Mediates Lab User conflicts with the authority to escalate issues to direct supervisors
    • Manages lab documentation to ensure Quality, Safety and departmental compliance. Reviews and ensures equipment/instrumentation documentation (log sheets, chart recorders) is compliant with Good Documentation Practices. Resolves documentation issues with equipment users
    • Acts and serves as point of contact with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation, calibration and validation of new non- Roche branded equipment
    • Coordinates calibration, certification, relocation and repair of existing equipment with Instrument /Facilities/Calibration team to minimize impact on project teams needing access to equipment
    • Mentors/coaches other Lab Supervisors, provides training and seeks opportunities to develop skills
    • Participates in the on-call services for CTU excursion
    Online seit: Fri Oct 18 13:43:53 CEST 2024
    Referenznummer: 788053/1

    Field IT Service Coordinator (m/f/d)

    Freelance/temporary employment for a project
    Mumbai
    • Translate business needs into business solutions, including technical recommendations
    • Participate in and execute business/operation process improvement related to IT with function managers
    • Participate in and lead projects, such as tech upgrades and rollout of new software and technology
    • Uphold and follow IT standards and directives 
    • Provide 1.5 and 2nd partial 1 and 1.5 level support locally
    • Responsible for IT service in India, including software/hardware support, network connectivity support, and local application support
    • Provide IT-related training and coaching to users
    • Travel as required to other locations in India and region (APAC) to support or for projects
    • Hands-on experience in setting up computers in a Microsoft Windows environment, Windows Server, and Active Directory administration 
    • Knowledge of switch management/configuration, network administration and management, and Microsoft 365 IT support
    Online seit: Tue Oct 15 11:59:08 CEST 2024
    Referenznummer: 788175/1

    Head of Human Factors & Medical (m/f/d)

    Bern
    • Lead and manage a department of Medical Affairs specialists and a Human Factors team, designing and implementing a business-driven "Science & Evidence" roadmap to support current and future drug delivery devices
    • Drive user-centered, evidence-based initiatives to ensure the safe and effective use of our products
    • Lead cross-functional collaboration with innovation, development, marketing, and regulatory teams to develop impactful strategies and deliver key programs
    • Provide insights into market trends and patient therapy needs to shape new drug delivery platforms aligned with the pharma/biotech pipeline
    • Analyze drug trial results and competitor products to inform strategic decisions and support business growth
    • Ensure smooth regulatory approval processes, including clinical evaluations, for timely market access of new products
    • Oversee design validation of drug-device combination products to ensure safety and efficacy, and develop training programs and scientific materials to promote the benefits of our solutions
    Online seit: Tue Oct 15 08:57:23 CEST 2024
    Referenznummer: 787831/1

    CSV Engineer (m/f/d)

    Freelance/temporary employment for a project
    Stein, Aargau
    • Acting as subject matter expert (SME) on following Lonza CQV / CSV standards
    • CSV person of contact of the assigned system till the handover to the operation organization
    • Participate to the system impact assessment as CSV SME
    • Define with EMR and Package Units vendor the most appropriate design for vertical integration in the Lonza environment
    • Create the requested CSV documents according Lonza SOP’s and Guidelines
    • Organize the reviews of the CSV documents till last QA approval
    • Participate to the FAT & SAT
    • Create the tests protocols and execute the tests
    • Close collaboration with CSV Lead or CQV Lead
    Online seit: Fri Oct 11 16:39:58 CEST 2024
    Referenznummer: 786599/1

    Medical Alliance Operations Leader (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Process Development and Implementation: Develop, optimize, and implement clinical research processes and procedures to ensure efficient and compliant study conduct
    • Process Infrastructure Development: Establish and maintain process infrastructures to support clinical research activities
    • Process Oversight and Quality Management: Monitor and manage clinical research processes to ensure quality and compliance with applicable regulations and standards
    • Study Team Coaching and Training: Provide guidance, training, and support to study teams to enhance their understanding of clinical research processes and regulatory requirements
    • Support Inspection and Audit Preparation and Follow-up: Prepare for and support inspections and audits by regulatory authorities and other external stakeholders; manage follow-up actions as necessary
    • Issue and Finding Management and Resolution: Identify, investigate, and resolve issues and findings related to clinical research processes
    • Stakeholder Management and Engagement: Engage and collaborate with internal and external stakeholders to ensure smooth and effective management of clinical research activities
    • Communication and Interpersonal Skills: Demonstrate strong communication and interpersonal skills to effectively convey information and build relationships with stakeholders
    Online seit: Fri Oct 04 15:11:30 CEST 2024

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    Referenznummer: 786272/1

    CQ Documentation Preparation Lead 100% (m/f/d)

    Freelance/temporary employment for a project
    Valais
    • Ensure documentation consistency across the CQ group and manage COMOS / KNEAT / DMS interfaces for CQ group
    • Responsible for documentation management for the project CQV group. Creating templates, first-of-kinds, alignment across group, approval process, retention process, etc.
    • Coordination of Operational Qualification Protocol preparation and approvals, including release for OQ and PQ
    • Coordination of GMP regulations and management of the training programme for Commissioning and Qualification activities
    • Coordination and communication with other resources for Qualification / Documentation Management activities
    • Self-manage CQ development review / approval activities with respect to COMOS/KNEAT platforms
    Online seit: Wed Oct 02 14:31:11 CEST 2024
    Referenznummer: 786277/1

    CQ Lead, Fill & Finish (m/f/d)

    Freelance/temporary employment for a project
    Aargau
    • Ensure that CQV activities are executed in accordance with the C&Q Plan and supporting Validation Plans
    • Overall planning and execution of the commissioning activities related to allocated areas or systems
    • Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
    • Planning and scheduling the commissioning activities according to the C&Q strategy and supporting Validation Plans
    • Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle
    • Support development of C&Q schedule by including the activities relevant for the preparation of commissioning test plans and test specifications
    • Coordinating the planning and scheduling of commissioning activities with the construction interface and with other disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)
    Online seit: Wed Oct 02 14:15:52 CEST 2024
    Referenznummer: 786273/1

    SAP MM Consultant (m/f/d)

    Basel Stadt
    • Work with clients to understand their business requirements and design and implement solutions that meet those requirements
    • Participate in requirements gathering discussions with client. Clearly document the business requirements and perform fit-gap analysis
    • Translate business requirements into appropriate functional solutions while assessing feasibility and optimization of the solution
    • Configure the SAP MM module to meet client requirements
    • Document functional specifications based on business requirements
    • Develop and execute proof of concepts to demonstrate feasibility of proposed solutions
    • Work with other SAP consultants to ensure that the SAP MM module is integrated with other SAP modules, such as FI (Financial Accounting) and CO (Controlling)
    Online seit: Wed Oct 02 10:36:57 CEST 2024
    Referenznummer: 785892/1

    Regional Regulatory Lead (m/f/d)

    Freelance/temporary employment for a project
    Bern
    • Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries
    • Align all regulatory activities with regional and global strategies, ensuring compliance with local requirements
    • Communicate effectively to ensure that dossiers meet regional and local content and format requirements
    • Coordinate, compile and track high-quality documentation for submissions, including new license applications and lifecycle activities to enhance connectivity and improve submission and approval timelines. This also involves addressing questions related to regulatory submissions
    • Build strong relationships with regional regulatory agencies, utilizing negotiation and influencing skills for positive outcomes
    • Collaborate with internal functions e.g., Commercial, Manufacturing, Supply Chain, and Medical Affairs to enhance connectivity
    • Stay informed about international legislation and guidelines for biological products and related initiatives e.g., rare diseases, orphan drugs
    Online seit: Mon Sep 30 15:06:44 CEST 2024
    Referenznummer: 783868/1

    Kubernetes Atlassian SecDevOps Engineer (m/f/d)

    Freelance/temporary employment for a project
    Visp, Valais, Switzerland
    • Responsible for designing and maintaing containerized solutions
    • Design and implement cloud or on-premise infrastructure for IT and OT together with the IT and OT infrastructure representatives which need to meet the highest levels of GxP requirements, IT security controls and reliability.Define cloud standards and frameworks in order to manage the entire infrastructure lifecycle with DevOps techniques and technologies like: Hardware provisioning (Infrastructure as code), CI/CD pipelines, Testing automation framework, Artifact repositories (Releases, images...), Logs management and aggregation, Events/Metrics management and aggregation, Alert system, Apps building and deployment and Authentication and security framework
    • Responsible for proper Design according to IT Security and QA standards and procedures conducting reviews against architecture standardsEnsure that forward looking architectures, including new applications, move to cloud native setups. In order to provide a single pane of glass for IT and OT management, strengthen business resilience, etc.
    • Ensure that forward looking architectures, including new applications, move to cloud native setups. In order to provide a single pane of glass for IT and OT management, strengthen business resilience, etc.
    • Define, drive and implement new working methodologies using modern agile approach in collaboration with relevant stakeholders.
    • Look for improvements and enhancements to infrastructure systems that will ultimately provide more efficient services to the business
    Online seit: Fri Sep 20 15:09:36 CEST 2024
    Referenznummer: 784041/1

    CSV Specialist (m/f/d)

    Freelance/temporary employment for a project
    Neuchatel
    • Support and interface with process owners of systems and take part in daily activities upon request (provide technical and statistical support)
    • Execute and documents Equipment & Software validation
    • Oversee validation and qualification activities executed by analysts, provide training and support
    • Ensure cGMP compliant and timely implementation and maintenance of validated status of systems
    • Conduct/participate in risk assessments, root cause analysis and investigations
    • Identify, lead and drive improvements or change
    • Provide technical assessments on protocols deviations and investigations
    • Serve as SME for internal technical group discussions
    Online seit: Thu Sep 19 13:27:24 CEST 2024
    Referenznummer: 781052/1

    Senior Expert Science & Technology – Functional Lead in Biologics – Global Drug Development (m/f/d)

    Basel Stadt
    • Independently design, plan, organize and perform scientific experiments for the preparation and timely delivery of biologic drug products (DP), processes and procedures
    • Independently design, plan, organize and perform specific analytical tests related to the experiments as well as for related stability studies
    • Documentation of raw data from the scientific experiments including all conducted analytical tests as well as evaluation. interpretation and reporting of all results of the scientific experiments together with the project responsible (Functional Lead)
    • Interprets results including drawing relevant conclusions and delivers respective work packages to meet agreed objectives & timelines in the project team. Ensures and drives information exchange in DP sub-team
    • You will be a core member of the Drug Product development sub-team, representing the scientific and technical excellence and you might be a member of the CMC team ad-hoc if required
    • Based on the project status, participate in function-specific project sub team meetings and discussions
    • If required, support the compilation of scientific protocols / reports and lab procedures based on existing templates as well as contribute to compilation of SOPs
    • Take over responsibility for specific tools / equipment and utilize special tools / equipment or specialized facilities as an expert
    • Schedule and perform maintenance and qualification of tools / instruments / equipment as needed
    • Develop new methods or optimize existing laboratory methods/processes as well as contribute to development and implementation of new technologies
    Online seit: Fri Aug 30 13:21:55 CEST 2024
    Referenznummer: 780419/1

    Scientist Immunology and Cardiovascular/Metabolic Disease (LSW) - BS (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Carefully design, organize, and manage externally run studies in collaboration with internal scientists, procurement and contract research organizations in a timely manner
    • Act as an advisor for study design: Define scientific rationale, success metrics and monitor progress
    • Provide high quality analysis of conducted studies and summarize, present and discuss study results with project teams
    • Ensure excellent interaction with vendors and maintain overview on activities and capabilities of relevant CROs
    • Work on a flexible schedule to meet deadlines
    Online seit: Tue Aug 27 11:29:41 CEST 2024
    Referenznummer: 780194/1

    Senior Scientist Tech transfer (m/f/d)

    Freelance/temporary employment for a project
    Neuchatel
    • Responsible for supporting commercial manufacturing performance at the external manufacturing site
    • Represents MS&T external manufacturing team to provide technical support to the biological drug substance tech transfer process including deviation resolution, change management, delivery of yield targets and process optimization
    • Maintains strong working relationships with external and internal partner
    • Interface with internal functions such as MS&T, Quality, and Supply Chain
    • Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving
    • Tracks progress of routine manufacturing against schedule, provides routine updates and proactively identifies operational risks and remediation
    • Ensures timely escalation of potential technical, compliance or safety issues to the MS&T team and partners with internal MS&T resources to remediate
    • Ensures effective communication between technical transfer internal and external team
    • Support technology transfer activities as a primary duties
    • Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements
    Online seit: Mon Aug 26 14:29:30 CEST 2024
    Referenznummer: 780127/1

    QA Associate QMS (m/f/d)

    Freelance/temporary employment for a project
    Basel Stadt
    • Receives incoming documents e.g. executed batch records, work orders, vendor labels, packaging instructions etc.
    • Performs documentation in respective tools. Prepares documentation needed for the batch record review e.g. Analysis Reports, Specifications for clinical development, country label approval etc.
    • Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products
    • Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels, Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility e.g. CoC's, BRR Checklists
    • Scan, file and archive documents owned by QA e.g. Certificate of Compliance, Batch Record Review Checklists
    • Write and review procedures and forms related to the QA Batch record Review Process
    • Contributes to Right First Time performance reports for release of IMPs
    • Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes
    • Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes
    Online seit: Mon Aug 26 09:40:22 CEST 2024
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