3 joburi disponibile

Product Safety Specialist - Material Declaration (f/m/d) - IVD product development/EHS data management/German/SAP EHS/SAP MM/agile Project: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Product Safety Specialist - Material Declaration Background: As Product Safety Specialist (m/f/d) you will be a member of our global unit "Diagnostics Product Sustainability & Compliance". The Compliance Operations department is responsible for the data and processes within Diagnostics Quality & Regulatory that enable a chemical and environmentally compliant and sustainable development, transport/handling, marketing and disposal of all Roche Diagnostics products (the so-called product life cycle). This means that we are not only irreplaceable in ensuring compliance in the interests of our patients, but also pursue the goal of significantly and sustainably reducing the environmental impact of all our products and services. In order to be able to continue to do this successfully, we are now looking for YOU! The perfect candidate has completed studies in in environmental sciences, natural sciences, engineering, information sciences or comparable and min. 3-5 years of professional experience in IVD product development or manufacturing or in the product safety environment (material declaration, product stewardship) or EHS data management. The candidate has experience in the pharmaceutical, (medical) device, electronics or automotive industry and a sound understanding of the chemical composition of materials, especially those used in diagnostic products and packaging. Experience with (global) chemical and environmental regulatory legislation is required. Tasks & Responsibilities: . Contact person (1st level support) for Data Requests from Customers regarding relevant chemical and environmental regulatory data for Chemical Legislation for the Diagnostic Instruments and Articles, such as REACH, RoHS, POP, TSCA, California Proposition 65, Batteries Directive, WEEE, Packaging Directive, EPR topics. . Interacting directly with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of EH&S (Environmental Health & Safety) Data following company standard using appropriate IT tools (eg SAP Production Systems, EH&S(M) . Data management and EH&S data maintenance in SAP EH&S(M) and in future, S/4HANA and chemical law evaluation of our products (articles) as part of the material declaration E2E processes . Continuous further development of the EHS data management data, process and system architecture . Eliminate waste by radically simplifying processes with an emphasis on automating redundant manual processes and foster automated report creation for the network using tools such as RPA (Robotics Process Automation, .Google App Scripts, Tableaux etc.) . Key user for the EH&S data management tools (support in determining system properties, monitoring periodic implementation processes by reviewing requirements and test cases) . Ensuring data conformity, quality and integrity (according to data model); as well as carrying out plausibility checks . Providing Quality oversight for Roche Diagnostics Direct Material Suppliers for the Roche Instruments (existing and in Development). Responsibility includes managing Supplier EH&S Data Questionnaires for Chemical Legislation. As a sub-chapter member: . You bring a mix of passion, functional knowledge and drive for client interests to your work to inspire, motivate and lead squads within the network and the chapter. . You are committed to cross-functional collaboration and breaking down silos to achieve the best results for the organization . You have the ability to navigate a changing organization, maintain objectivity, respect differences of opinion, fairness, open communication and develop Must Haves: . Completed studies in in environmental sciences, natural sciences, engineering, information sciences or comparable . Min. 3-5 years of professional experience in IVD product development or manufacturing or in the product safety environment (material declaration, product stewardship) or EHS data management . Experience in the pharmaceutical, (medical) device, electronics or automotive industry . Sound understanding of the chemical composition of materials, especially those used in diagnostic products and packaging . Experience with (global) chemical and environmental regulatory legislation (eg REACH, RoHS, WEEE, California Proposition 65, TSCA, California Proposition 65, Batteries Directive, WEEE, Packaging Directive, EPR topics) . Affinity for handling large amounts of data, process automation and a preference for data science for Supplier Governance and Oversight . Understanding of system and data management, especially in SAP modules such as SAP EHS or SAP MM, to effectively manage material declarations and compliance documentation . Relevant experience working with applicable processes or IT systems (eg SAP EH&S) . Relevant experience working with automation tools, eg Robotics Process Automation (RPA), Google App Scripts etc. . Fluent in English, German and any other language is a plus . Negotiation skills and efficient communication characterize you . Able to skilfully place requests for material information with suppliers and obtain material declarations from suppliers . Able to build and maintain trusting and profitable relationships with important supplier Nice to Have:  . Relevant experience working in the Medical Device industry on EH&S topics . First experience and expertise in agile project management or working in an agile environment Reference Nr.: 923842SGR Role: Product Safety Specialist - Material Declaration Industry: Pharma Workplace: Basel Pensum: 100% Start: 01.02.2025 Duration: 12 Travel : 5% Deadline : 09.01.2025 If you are interested in this position, please send us your complete dossier via the link in this advertisement.  About us : ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering. We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.

Job Title: Regulatory Subject Matter Expert (SME), Data & AI Location: United Kingdom Industry: Global Pharmaceutical/Biotechnology Company Size: Large Enterprise TechNET-IT is working with a leading organisation in the global pharmaceutical and biotechnology industry, currently seeking a Regulatory Subject Matter Expert (SME), Data & AI to join their dynamic team. This is an exciting opportunity to play a crucial role in ensuring compliance with regulatory requirements while leveraging data and AI in the development of life-changing therapies. Key Responsibilities: Regulatory Guidance: Provide expertise on global regulations and guidelines (FDA, EMA, MHRA) related to the use of data and artificial intelligence in pharmaceutical research, development, and commercialisation. AI & Data Compliance: Ensure AI models, machine learning algorithms, and data governance processes adhere to regulatory and ethical standards. Cross-Functional Collaboration : Work closely with data science, IT, clinical, and regulatory teams to ensure seamless integration of AI and data strategies in drug development and patient safety processes. Regulatory Submissions : Support the preparation and review of regulatory submissions that involve AI-driven processes or data use. Monitoring & Reporting: Keep abreast of changes in regulatory requirements related to data and AI, and ensure compliance with evolving standards. Risk Management: Identify potential compliance risks related to AI and data use, and propose mitigation strategies. Handover & Training: Collaborate with internal teams to ensure understanding and adherence to regulatory requirements and best practices for data and AI use. Key Requirements : Experience in Regulatory Affairs: Proven experience in regulatory roles within the pharmaceutical, biotech, or healthcare industry, particularly with a focus on drug development, clinical trials, and regulatory submissions. AI & Data Knowledge: Solid understanding of data science, machine learning, and AI technologies, particularly as applied to pharmaceuticals or healthcare. Educational Background: Degree in life sciences, regulatory affairs, data science, computer science, or a related field. Additional certifications in regulatory affairs and/or AI/data governance would be an advantage. Pharmaceutical Experience: Previous experience working in large-scale pharma, biotech, or healthcare companies, particularly in projects involving AI and data. Regulatory Expertise : Deep knowledge of international regulatory frameworks (FDA, EMA, MHRA, GDPR, etc.) and compliance standards related to AI and data usage. Strong Communication Skills: Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams. Problem-Solving Ability: Skilled in identifying and addressing regulatory challenges in AI and data initiatives. What's on Offer: Competitive salary and benefits package The opportunity to work with cutting-edge AI and data technologies in a fast-growing, innovative pharmaceutical/biotech environment Collaboration with cross-functional teams on impactful projects shaping the future of drug development If you have a passion for ensuring compliance in the rapidly evolving intersection of data, AI, and pharmaceuticals, we'd love to hear from you! TechNET-IT is assisting this client in their search for a top candidate. If you're interested in this position, please apply directly or contact us for more information.

Job Title: Regulatory Subject Matter Expert (SME), Data & AI Location: Barcelona Industry: Global Pharmaceutical/Biotechnology Company Size: Large enterprise TechNET-IT is working with a leading organisation in the global pharmaceutical and biotechnology industry, currently seeking a Regulatory Subject Matter Expert (SME), Data & AI to join their dynamic team. This is an exciting opportunity to play a crucial role in ensuring compliance with regulatory requirements while leveraging data and AI in the development of life-changing therapies. Key Responsibilities: Regulatory Guidance: Provide expertise on global regulations and guidelines (FDA, EMA, MHRA) related to the use of data and artificial intelligence in pharmaceutical research, development, and commercialisation. AI & Data Compliance: Ensure AI models, machine learning algorithms, and data governance processes adhere to regulatory and ethical standards. Cross-Functional Collaboration: Work closely with data science, IT, clinical, and regulatory teams to ensure seamless integration of AI and data strategies in drug development and patient safety processes. Regulatory Submissions: Support the preparation and review of regulatory submissions that involve AI-driven processes or data use. Monitoring & Reporting: Keep abreast of changes in regulatory requirements related to data and AI, and ensure compliance with evolving standards. Risk Management: Identify potential compliance risks related to AI and data use, and propose mitigation strategies. Handover & Training: Collaborate with internal teams to ensure understanding and adherence to regulatory requirements and best practices for data and AI use. Key Requirements: Experience in Regulatory Affairs: Proven experience in regulatory roles within the pharmaceutical, biotech, or healthcare industry, particularly with a focus on drug development, clinical trials, and regulatory submissions. AI & Data Knowledge: Solid understanding of data science, machine learning, and AI technologies, particularly as applied to pharmaceuticals or healthcare. Educational Background: Degree in life sciences, regulatory affairs, data science, computer science, or a related field. Additional certifications in regulatory affairs and/or AI/data governance would be an advantage. Pharmaceutical Experience: Previous experience working in large-scale pharma, biotech, or healthcare companies, particularly in projects involving AI and data. Regulatory Expertise: Deep knowledge of international regulatory frameworks (FDA, EMA, MHRA, GDPR, etc.) and compliance standards related to AI and data usage. Strong Communication Skills: Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams. Problem-Solving Ability: Skilled in identifying and addressing regulatory challenges in AI and data initiatives. What's on Offer: Competitive salary and benefits package The opportunity to work with cutting-edge AI and data technologies in a fast-growing, innovative pharmaceutical/biotech environment Collaboration with cross-functional teams on impactful projects shaping the future of drug development If you have a passion for ensuring compliance in the rapidly evolving intersection of data, AI, and pharmaceuticals, we'd love to hear from you! TechNET-IT is assisting this client in their search for a top candidate. If you're interested in this position, please apply directly or contact us for more information.