Product Safety Specialist
vor 8 Stunden
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 environmental sciences, natural sciences, engineering, information sciences, or comparable fields and has a minimum of 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 standards 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 fostering automated report creation for the network using tools such as RPA (Robotics Process Automation), Google App Scripts, Tableau, 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 environmental sciences, natural sciences, engineering, information sciences, or comparable.
- Minimum 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, Batteries Directive, 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 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 suppliers.
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. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive Payroll-Only programme: +41 41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes 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.
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