Product Safety Specialist – Material Declaration

vor 1 Tag

Basel, Schweiz ITech Consult Vollzeit

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 ensure compliance in the interests of our patients while pursuing the goal of significantly and sustainably reducing the environmental impact of all our products and services. In order to continue 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, with a minimum of 3-5 years of professional experience in IVD product development, manufacturing, or in the product safety environment (material declaration, product stewardship) or EHS data management. The candidate should have 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:

  • Act as the 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, and EPR topics.
  • Interact 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)).
  • Manage data and EH&S data maintenance in SAP EH&S(M) and, in future, S/4HANA, including chemical law evaluation of our products (articles) as part of the material declaration E2E processes.
  • Continuously develop the EHS data management data, process, and system architecture.
  • Eliminate waste by simplifying processes with an emphasis on automating redundant manual processes and fostering automated report creation using tools such as RPA (Robotics Process Automation), Google App Scripts, Tableau, etc.
  • Serve as a key user for the EH&S data management tools, supporting the determination of system properties and monitoring periodic implementation processes by reviewing requirements and test cases.
  • Ensure data conformity, quality, and integrity (according to the data model) and carry out plausibility checks.
  • Provide quality oversight for Roche Diagnostics Direct Material Suppliers for Roche Instruments (existing and in development), managing Supplier EH&S Data Questionnaires for Chemical Legislation.

As a sub-chapter member:

  • Bring a mix of passion, functional knowledge, and drive for client interests to inspire, motivate, and lead squads within the network and the chapter.
  • Commit to cross-functional collaboration and breaking down silos to achieve the best results for the organization.
  • Navigate a changing organization, maintain objectivity, respect differences of opinion, fairness, open communication, and development.

Must Haves:
* Completed studies in environmental sciences, natural sciences, engineering, information sciences, or comparable fields.
* Minimum 3-5 years of professional experience in IVD product development, 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.
* Strong negotiation skills and efficient communication.
* Ability to skillfully place requests for material information with suppliers and obtain material declarations.
* Ability 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

Job Type: 100%

Work Location: On the road

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