POSITION Globally responsible for product regulatory compliance regarding food contact materials, cosmetic and pharmaceutical packaging for Flint Group manufactured and resale products Managing and developing the global regulatory team, mainly located in Europe and the US, and ensuring close alignment with the various stakeholders in the divisions Defining and executing the regulatory affairs strategy and implementing policies, guidelines and best practices Developing and maintaining accurate and up to date regulatory digital documentation and paperwork towards customers; ensuring timely and complete response to regulatory requests Driving projects to achieve and maintain international and/or national regulatory compliance for new and existing products Performing and/or organizing risk assessments for substances used/present in the products based on scientifically acceptable methods Liaising and negotiating when necessary with regulatory authorities Representing or coordinating representation of Flint Group in trade associations; communicating the necessary information to the regulatory and/or business teams Designing scenarios for possible future developments and implications Reporting to the Senior Director Product Stewardship & Regulatory Affairs.
Own and Manage Regulatory Processes and Risk Take full responsibility for all regulatory processes within the team, ensuring timely execution and proactive risk management across the entire regulatory scope. Support Cross-Functional Projects and Process Optimization Provide comprehensive regulatory expertise to internal functions and project teams (e.g. manufacturing transfers).
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
As a Principal Biostatistician you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions.Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.
ZEISS sucht in eine/n Manager Labeling & Regulatory Projects (f/m/x) (ID-Nummer: 13753083)
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
Act as a Senior Finance Business Partner for R&D, Quality/Regulatory, and Medical Affairs, providing financial insights and decision support to senior stakeholders Lead project controlling for R&D projects and clinical studies, including budgeting, forecasting, cost tracking, and performance analysis Ensure transparency of project costs, resource utilization, and key cost drivers to enable effective financial steering of development activities Drive the standardization and continuous improvement of controlling processes, KPIs, and reporting tools across the organization Serve as SAP Key User for CO and PS, supporting project structures, cost allocation logic, and reporting, as well as contributing to SAP ECC6 and S/4HANA implementation and optimization initiatives Degree in Business Administration, Finance, Controlling, or a related field Robust experience in controlling, preferably within the Life Sciences, MedTech, or Pharmaceutical industry Strong background in project controlling for R&D projects or clinical studies, including business case evaluation and financial performance management Advanced SAP expertise, particularly in SAP CO and PS, with experience using SAP BW / Analysis for Office and advanced Excel reporting Proven business partnering and stakeholder management skills, with the ability to challenge senior leaders in a constructive manner; fluent English and solid German skills required Challenging and varied tasks in a promising and innovative industry Flat hierarchies Individual development opportunities Ihr Kontakt Referenznummer 865253/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
Act as a Senior Finance Business Partner for R&D, Quality/Regulatory, and Medical Affairs, providing financial insights and decision support to senior stakeholdersLead project controlling for R&D projects and clinical studies, including budgeting, forecasting, cost tracking, and performance analysisEnsure transparency of project costs, resource utilization, and key cost drivers to enable effective financial steering of development activitiesDrive the standardization and continuous improvement of controlling processes, KPIs, and reporting tools across the organizationServe as SAP Key User for CO and PS, supporting project structures, cost allocation logic, and reporting, as well as contributing to SAP ECC6 and S/4HANA implementation and optimization initiatives Degree in Business Administration, Finance, Controlling, or a related fieldRobust experience in controlling, preferably within the Life Sciences, MedTech, or Pharmaceutical industryStrong background in project controlling for R&D projects or clinical studies, including business case evaluation and financial performance managementAdvanced SAP expertise, particularly in SAP CO and PS, with experience using SAP BW / Analysis for Office and advanced Excel reportingProven business partnering and stakeholder management skills, with the ability to challenge senior leaders in a constructive manner; fluent English and solid German skills required Challenging and varied tasks in a promising and innovative industry Flat hierarchies Individual development opportunities Ihr Kontakt Referenznummer 865253/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
If you have experience with consumer healthcare customer interaction it is a great advantage. You have a proven track record of running global projects showcasing your ability to lead in-directly and making a positive impact on business and collaborations. Strong communication skills are key to success and besides fluency in English (written and spoken) you have an in-ternational mindset and the ability to work in a matrix environment.
If you have experience with consumer healthcare customer interaction it is a great advantage. You have a proven track record of running global projects showcasing your ability to lead indirectly and making a positive impact on business and collaborations. Strong communication skills are key to success and besides fluency in English (written and spoken) you have an international mindset and the ability to work in a matrix environment.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
Job Overview: As an Associate Director, Biostatistics, with regional/site presence, you will manage a team of Biostatistics staff and fulfil the role of site head or functional head within a site. You will provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.
Executive Reporting and Stakeholder Communication Provide strategic updates, risk assessments, and clear go/no-go recommendations to the department and company leadership. Drive stakeholder alignment by translating project complexity into concise, action-oriented insights. Your Profile: Master's degree in Business Management, Business Administration or comparable At least 5 - 10 years of relevant professional experience in Project Planning and Risk Management in the pharmaceutical industry (must-have) Excellent analytical and problem-solving skills with a strategic, results-driven approach A persuasive and resilient professional with excellent communication and relationship-building skills You are confident in using standard MS Office programs and project management tools (MS Project, Planner etc.)
Presenting project progress and critical issues to steering committees Your Profile: Completed degree in business administration, engineering, or a comparable field Required professional experience: 5 years, ideally in the area of supply chain or project management Alternatively, you have experience in regulatory affairs, quality assurance, or pharmacovigilance You already have some experience in coordinating cross functional teams and complex projects You are characterized by analytical thinking and a structured and results-oriented approach to work You communicate and negotiate confidently in German and English and have a good working knowledge of MS Office; knowledge of SAP is an advantage Your way of working is proactive, solution-oriented and communicative Unser Angebot: A growing company with a diverse and open-minded working environment with employees from around 40 different countries Flexible working models adapted to your needs (e.g. up to 100% remote working and up to two months from abroad within the EU possible), working time account with time off in lieu, 30 days' holiday Flexible benefits budget that you can use according to your individual preferences, such as a higher employer contribution to the company pension scheme, fitness & health offers or subsidies for travel or meal costs.
You’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas and in covering projects in Germany, Austria and Switzerland. Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.
7-10 years professional experience in logistics industryIdeally a recognized LSHC qualification Project management education, e.g. DePICT, Prince2 Change Management and Executive Presentations skills Extensive knowledge of LSHC requirements or any other regulatory requirements applicable in the industry Extensive knowledge of Supply Chain operations, warehouses, sites Experience of working in a complex regional/global matrix environmentExposure to working on large, complex projects or operations Able to ramp-up quickly on new topics as well as dive into and understand operational content Excellent analytical and problem solving skills Strong people and stakeholder management skills Outstanding communication skills and ability to influence at a senior level Fluent in English, any additional European Languages is a plusProficient with MS Office suite (MS Word, Excel, PowerPoint, Project, Visio), BPMA tool
As a national and international personnel services provider, we can offer you both short-term projects and long-term opportunities in your local area, nationwide and around the world – all free of charge to you. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Register with us and reap the benefits of interesting job offers that match your skills and experience. Responsible for project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet facility production throughput demands Leads multi-disciplinary Teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements Develops and maintains integrated project plans and monitors project activities for adherence to milestone timelines, deliverables and budget against approved plan.
Requirements Chief Engineer / Second Engineer license or degree in Naval Architecture / Marine Engineering Minimum 5 years seagoing or relevant technical experience, including at least 1 year in a shore-based role Strong knowledge of international maritime regulations and vessel technical systems Fluent English skills and confident use of common IT tools Analytical mindset, strong communication skills, and structured working style Willingness to travel internationally on a regular basis Valid work authorization for / residence in Germany is advantageous Benefits Diverse technical role within a global maritime environment at one of the market leaders Modern office environment in central Hamburg Career development opportunities within an international organisation Public transport contribution and additional, individual employee benefits Responsibilities Monitor the technical and operational performance of assigned container vessels Initiate inspections, define repair scopes, and coordinate procurement in line with class and regulatory requirements Supervise technical interventions and liaise with shipyards, classification societies, and service providers Review technical incidents, challenge root cause analyses, and implement continuous improvement measures Act as primary contact for captains, chief engineers, internal stakeholders, and external partners Prepare and control vessel budgets and support cost optimisation initiatives Maintain vessel documentation, certificates, and compliance with international maritime regulations Monitor fuel, oil, and technical consumption and support efficiency improvements Travel to vessels, ports, and project sites as required Informationen über den Arbeitgeber Our client is a global maritime organisation managing a modern fleet of container vessels.
As a national and international personnel services provider, we can offer you both short-term projects and long-term opportunities in your local area, nationwide and around the world – all free of charge to you. Register with us and reap the benefits of interesting job offers that match your skills and experience.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas.
Register now and look forward to many interesting and suitable positions and projects. Coordinate activities within the transformation program across defined workstreams Refine program scope, timelines, and budget as required Prepare materials and documentation for steering committee meetings Maintain RAID logs, coordinate project related communication and escalations with stakeholders Prepare decision proposals and support the transparent execution of the program Ensure all program activities comply with regulatory requirements and quality standards (e.g., GMP, GAMP, ISO standards) Apply established methods and tools for quality assurance and project coordination (e.g., SAP, QMS, TrackWise, CAPA) Align with multiple stakeholders, including senior managers and subject matter experts, to ensure successful program delivery Knowledge in GMP Knowledge in GAMP Knowledge in SAP Knowledge in QMS Knowledge in TrackWise Knowledge in CAPA Possibility of extending the project Ihr Kontakt Ansprechpartner Daniel Grudentaler Referenznummer 865825/1 Kontakt aufnehmen E-Mail: daniel.grudentaler@hays.de Anstellungsart Freiberuflich für ein Projekt
Register now and look forward to many interesting and suitable positions and projects. Coordinate activities within the transformation program across defined workstreamsRefine program scope, timelines, and budget as requiredPrepare materials and documentation for steering committee meetings Maintain RAID logs, coordinate project related communication and escalations with stakeholders Prepare decision proposals and support the transparent execution of the program Ensure all program activities comply with regulatory requirements and quality standards (e.g., GMP, GAMP, ISO standards) Apply established methods and tools for quality assurance and project coordination (e.g., SAP, QMS, TrackWise, CAPA) Align with multiple stakeholders, including senior managers and subject matter experts, to ensure successful program delivery Knowledge in GMPKnowledge in GAMPKnowledge in SAPKnowledge in QMSKnowledge in TrackWiseKnowledge in CAPA Possibility of extending the project Ihr Kontakt Ansprechpartner Daniel Grudentaler Referenznummer 865825/1 Kontakt aufnehmen E-Mail: daniel.grudentaler@hays.de Anstellungsart Freiberuflich für ein Projekt
Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys CAGT strategy. Attends and presents at customer meeting, or bid defense or partnership meetings, as required.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas.
Responsible for the inclusion of Cardiovascular elements into proposals.Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys Cardiovascular strategy. Attends and presents at customer meeting, or bid defense or partnership meetings, as required.Participates in strategic business development activities including presentations to prospective clients and professional meetings.Maintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the Cardiovascular landscape.
Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys CNS strategy. Attends and presents at customer meeting, or bid defense or partnership meetings, as required.
We are looking for a skilled Engineering Project Manager (m/f/d) to lead and coordinate technical development projects related to Grid Code Compliance for wind turbines. In this role, you will be responsible for ensuring that our turbine platforms meet the latest regulatory requirements across various global markets.
We are looking for a skilled Engineering Project Manager (m/f/d) to lead and coordinate technical development projects related to Grid Code Compliance for wind turbines. In this role, you will be responsible for ensuring that our turbine platforms meet the latest regulatory requirements across various global markets.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas in Germany or the DACH region.
. • Strong communicator across functions. • Process‑oriented and structured. • Solid project management skills. • Proactive and solution‑oriented. • Comfortable in a fast‑paced, international environment. We are looking forward to your application and to applicants who enrich our diverse culture!
B. in Wirtschaftsingenieurwesen, Internationales Handelsmanagement, BWL, Supply Chain Management oder vergleichbarMehrjährige Berufserfahrung im GMP-regulierten Umfeld, idealerweise in der Pharmaindustrie oder pharmazeutischen Distribution z.B. als Compliance Manager, Regulatory Compliance Manager, GMP Compliance Manager / GMP Specialist, Project Manager / PMO Manager Quality & Compliance (m/w/d)Fundierte Kenntnisse in GxP, Quality Management, CAPA, Change ControlErfahrung im Projektmanagement (PMO-Strukturen)Sicherer Umgang mit SAP (idealerweise SAP BI) und MS OfficeSehr gute Deutsch- und Englischkenntnisse WIR GARANTIEREN IHNEN: Sie erwartet eine direkte Festanstellung bei unserem wertschätzenden Kunden.Um Sie bestmöglich bei unserem Kunden zu präsentieren, optimieren wir gemeinsam Ihre Bewerbungsunterlagen und bereiten Sie gründlich auf das Vorstellungsgespräch im Unternehmen vor.Damit Sie zu den besten Konditionen eingestellt werden, stehen wir Ihnen im Voraus zur Verhandlung Ihres Arbeitsvertrags beratend zur Seite.Darüber hinaus beraten wir Sie auch gern kostenfrei zu weiteren passenden Karrieremöglichkeiten.
Your assignments Producing designs, both initial outlines and full plans, of sewerage, water treatment and flood defence structures such as pump systems and pipe networksPresenting project details and technical information to colleagues and clientsWriting reportsManaging project budgetsKeeping up to date with changes in regulatory legislation and guidelinesWriting and advertising tender documents and managing contractsLiaising with clients, contractors, government agencies, local authorities and suppliersSupervising local staff and site workersUsing a variety of specialist computer applications/simulation softwareMaintain effective relationships with members of all divisions and departments responsible for performing services related to the projectPrepare construction cost estimates, perform construction monitoring and coordinate field activities Your profile University degree (M.Sc.) in civil engineer, mechanical engineer, process or environmental engineer or other suitable qualification Experience in the preparation of master plans, feasibility studies, tender documents and construction planning, and/or experience with construction supervision, project management and/or commissioning of water supply and/or wastewater treatment facilities.Preferably 5 years of professional experience in international consulting/engineering in the field of urban water management, preferably in projects financed by bilateral and multilateral donor organisations and development banksStructured approach to work a high degree of flexibility, initiative, persuasiveness and negotiation skills as well as the ability to work in a team Willingness to travel extensively Good knowledge of written and spoken English and preferably an additional business language (French, Spanish, etc.)
As well as contributing to the clinical workload, the successful candidate will have opportunities to be involved in training junior embryologists, service development, research, quality management, donor recruitment and project work. The Deputy Laboratory Manager will support the Laboratory Manager in the delivery of the service and management of the laboratory team.
As well as contributing to the clinical workload, the successful candidate will have opportunities to be involved in training junior embryologists, service development, research, quality management, donor recruitment and project work. The Deputy Laboratory Manager will support the Laboratory Manager in the delivery of the service and management of the laboratory team.
Register with us and reap the benefits of interesting job offers that match your skills and experience. Lead and manage the delivery of local CapEx projects in the area of Bulk and Fractionation-from feasibility through planning, execution, qualification, and validation-within the scope of the Global Engineering & Project Delivery (ENG/PD) organizationEnsure that all project phases comply with internal standards, regulatory requirements, and cGxP guidelinesCoordinate cross-functional project teams and external partners to achieve project goals in terms of scope, schedule, budget, and qualityOversee project documentation, risk management, contract management, and cost controlling throughout the project lifecycleDrive continuous improvement and identify optimization opportunities within engineering processes and project executionServe as the key point of contact for stakeholders, ensuring transparent communication and effective collaboration Bachelor’s, Master’s, or equivalent degree in Mechanical, Electrical, Process, or Chemical Engineering (B.Sc., M.Sc., Dipl.
Your Contribution Act as the primary technical point of contact for customers and Sales regarding OEM products, applications, and development needs.Serve as technical expert for assigned product groups; ensure specifications, requirements, and use conditions are fully understood and documented.Lead technical negotiations with customers, engaging as a peer and ensuring both technical and commercial alignment.Own product specifications for assigned OEM and standardized components.Evaluate feasibility of OEM inquiries; clarify technical questions with Technical Centers, Supply Chain Management, Product Management, Engineering, and Purchasing.Propose technical solutions and provide cost estimations in support of quotations and commercial opportunities.Lead or participate in customer-driven or strategic internal projects; coordinate prototype production, engineering samples, and technical evaluations.Drive internal and external approvals for changes in specifications, materials, supplier processes, or production methods.Perform competitive analysis and technology benchmarking to support product positioning and improvement.Provide technical documentation, application notes, and training materials; ensure all materials are accurate and up-to-date.Train Sales teams and, as needed, customers on new products, applications, and technologies.Support the Quality Department in resolving internal and customer complaints, including guiding root cause analysis and corrective actions.Contribute technical insights to global/regional product strategy, roadmap planning, and annual R&D activities.Establish and maintain product files (including medical product files when applicable).Ensure compliance with all Environmental, Health & Safety requirements.Perform additional duties as assigned to support SBF Medical's goals.
Develop and maintain software solutions by applying in-depth technical knowledge and problem-solving skills, while ensuring compliance with regulatory standards for medical softwareEnsure the timely delivery of high-quality software for medical devices that meets both the company's standards and customer needs, influencing the success of the team and broader project outcomesCommunicate complex technical concepts effectively, fostering an environment of collaboration and continuous learning within and across diverse and intercultural teamsEmpower your team members to take ownership of their work and leading by example to foster teamwork and mentorship Degree or equivalent practical experience in a specialized field related to software development or engineeringProven experience in software development, with a demonstrated passion and hands-on professional experience working with Rust incl. a solid understanding of Rust's core concepts (ownership, borrowing, and lifetimes), experience with asynchronous programming in Rust (e.g., using async/await) and familiarity with common Rust libraries and frameworks (e.g., tokio, actix-web, rocket, serde, sqlx).Capable of solving complex issues creatively and effectively, using a multi-faceted approach based on thorough analysis to resolve complex technical challengesExcellent communication skills with the ability to foster an inclusive and diverse environment as well as collaborate effectively within and across teamsEnglish fluency is a prerequisite, German is advantageous Internal career opportunitiesWorld-renowned medical devices company Ihr Kontakt Referenznummer 858105/1 Kontakt aufnehmen Telefon:+41 44 225 50 00 E-Mail: positionen@hays.ch Anstellungsart Freiberuflich für ein Projekt
Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards.
Transport gametes/embryos in accordance with regulations. Participate in research projects as needed. Communication: Attend lab/clinic meetings as directed by Lab Manager. Ensure effective communication with other departments and TFP.
You’ll bridge the gap between sales, medical, and operational teams to ensure seamless project execution and support sales teams throughout the Business Development process. RESPONSIBILITIES Actively collaborate with Sales, Medical, Operations, and other functions and provide guidance to ensure tailor-made strategies to project or programs that differentiate IQVIA from the competition resulting in compelling, feasible proposals and continuously drive business growth.Scan the therapeutic and operational landscape and take account of wider impacts to develop long term implementation strategies that maximize opportunities to add value.Maintain an understanding of current and future market trends that may impact current and/or future innovative operational delivery strategies.Act as champion for project centricity within the organization through enabling the project delivery team assigned to an awarded project to understand and implement the project strategy that was sold.Drive the team to leverage and consolidate all available data to build the project strategy.
· To build good relationships with suppliers in order to ensure good service and to facilitate participation in trials. · To help project the image of the clinic in professional and patient communities. Quality management · To develop and maintain standard operating procedures and new protocols as practices and technology develops
What you will do: Prepare and structure topics, requirements, and stakeholder requests Answer stakeholder questions and create clear, reliable documentation Support and drive new projects from concept phase to implementation Manage and refine incoming requests via the team’s ticketing workflow Derive and define development tasks based on business and data needs Analyze data flows and assess the impact of changes on existing data deliverables Evaluate new data sources and identify opportunities for process optimization Ensure transparency and quality of KPIs and financial data Who you are: 1+ years of experience in a Technical Business Analyst, Data, or similar role Hands-on mentality and strong willingness to learn Experience working with data and IT systems Solid SQL skills (BigQuery is a plus) Understanding of data structures and data flows Basic programming knowledge is a nice to have Additional information: **Working model: Due to the upcoming tasks and responsibilities for this position, it is required to work onsite at our headquarters in Hamburg or Berlin on a weekly basis.
Main job responsibilities: -English and Hungarian language – fluent (written and spoken) -Previous experience in managing an Operations/Warehouse, ideally in production environment, leadership experience, ability to build relationships with customers, - Capability to define strategic plan for the site, negotiation, project management and presentation skills
In this role, you will conduct quality audits, develop supplier management programs, and collaborate closely with international stakeholders, development teams, and operational units. Benefit from highly complex packaging projects, the highest quality standards, and the expertise of a specialist in pharmaceutical packaging solutions. Your tasks: Select and qualify packaging suppliers to ensure high-quality materials and collaborate with them to choose optimal packaging solutions for pharmaceutical products Lead global harmonization projects to standardize packaging specifications and processes, coordinating closely with international stakeholders from Operations Units and Innovation & Development Establish solid supplier requirements and contract these in supplier quality agreements Conduct quality audits at packaging manufacturers to review processes, improvements, and innovations while ensuring compliance with quality standards and mitigating supply chain risks Support Operational Units in resolving quality issues related to packaging materials through expert risk assessment and corrective actions Foster effective communication and seamless information exchange across the global packaging network, sharing best practices with international experts Contribute to the supplier management program by developing and refining standard operating procedures for supplier management activities Your qualifications Academic background in (Packaging) Engineering, Material Science, or a related technical field, complemented by a minimum of 3 years of relevant industry experience in packaging-related development, production, or quality assurance within the pharmaceutical or medical device sectorExtensive expertise in packaging production technologies and understanding of associated packaging defects for selected categories such as glass, rubber stoppers, thermoplastics, foils, and printed packaging, mainly used for IV solutionsStrong background in assessing primary packaging interactions with products, supported by experience in extractables and leachables studiesCompetencies in quality auditing packaging material suppliers and in-depth knowledge of GxP standards for packaging (e.g., ISO 15378) and regulatory procedures across Europe, the US, and ChinaBusiness fluency in both English and German, plus proficiency with IT tools such as MS Office, SharePoint, and SAP We offer you: A permanent employment contract Competitive salary Flexible working hours and home office options Opportunities for professional development and training Great working atmosphere and a highly motivated team Show us what moves and motivates you - apply now and be part of our inspiring company culture!
We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge.
Study Physician services Medical Content Oversight: Responsible for medical content in Clinical Trial Protocols (CTPs).Collaborates with Project Management, Patient Safety, Medical Writers, and trial/evidence teams.Provides medical input for CTP updates. Risk-Based Quality Management: Defines medically critical data/processes and associated risks.Contributes to Integrated Quality and Risk Management Plan (IQRMP).Participates in risk discussions during trial conduct.
As part of our team, you will take on the following responsibilities: You are responsible for the implementation, administration, monitoring, and maintenance of IT systems and services in a Windows Server environment, in compliance with defined security policies.You analyze and resolve incidents in 2nd- and 3rd-level support within the Windows Server infrastructure.You implement hardening measures to reliably meet regulatory, compliance, and security requirements.In addition, you ensure the continuous development of the systems, with a focus on security, efficiency, and stability, and guarantee stable operations as well as correct and efficient licensing within lifecycle management.You manage and monitor external service providers and ensure a high level of service quality.You conduct market analyses for the selection and evaluation of hardware and software products.You design and implement concepts for server and application operations in compliance with defined security policies.You plan, coordinate, and support IT projects and business sub-projects from realization through testing to rollout.You advise business departments on projects, changes, and adjustments to IT services, systems, and applications.You analyze and evaluate functional, technical, and business requirements and ensure their secure integration.You identify potential for process optimization, automation, and interface improvements and implement them sustainably.