Product Safety Specialist - Material Declaration (m/w/d)
Randstad (Switzerland) Ltd.
Veröffentlicht:
26 November 2024Pensum:
100%- Arbeitsort:Basel
job details
For one of our clients, an international pharma company in Basel, we are looking for a Product Safety Specialist - Material Declaration to join the 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 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.
General Information:
Tasks & Responsibilities:
As a sub-chapter member:
Must Haves:
Nice to Have:
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 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.
General Information:
- Start date: 1.01.2025
- Latest Start Date: 1.04.2025
- Planned duration: 1 year contract
- Extension: Likely
- Workplace: Basel
- Workload: 80-100%
- Home Office: max. 2 days per week
- Travel: 5%
- Working hours: Standard
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 (e.g. 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 Direct Material Suppliers for the 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 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 (e.g. 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 (e.g. SAP EH&S)
- Relevant experience working with automation tools, e.g. 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 skillfully 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
