job requisition id 202408-121509
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That's what makes us Roche.
The Opportunity Roche Diagnostics Cape Town is seeking a Custom Supply Specialist to join our Supply Chain and Logistics team.
You will serve as the single point of contact for local operations (manufacturing, QC, Logistics and supply chain) regarding the drafting and evaluation of new custom product specifications, supplying evaluation material through the Ad hoc ordering process, and coordinating/collecting subject matter experience from local functions. You will coordinate the activities and be accountable for the delivery of ad hoc material supply as well as ad hoc requests that may include, but are not limited to, specific customer questionnaires, memos, certificates, and complaint investigations.
Responsible for the day-to-day coordination and administrative tasks around ad hoc order management, fulfillment, and manufacturing including but not limited to KX unit determination, tracking of Purchase Order details, material reservation, packaging availability, vet certificates, quality memos, and communication with Hubs and affiliates/stakeholders involved as required.
Operations contributor for Custom projects where specific evaluation, input, and experience are needed from Operations.
For specifically ad hoc material requests: Integrate and collect feedback from departmental Single points of contact to ensure product flow through order management, planning, manufacturing, QC, and delivery to meet the turnaround objectives and commitments. Serves as the link between planning and order management e.g., material reservations and shipping requirements.
Works closely and aligns with Production Planners, team leads, and/or supervisors on any unique or special customer requests.
Executes and ensures completion of product documentation requests for quality, regulatory, and registration for Customers. Cross-functional collaboration with quality, research and development, manufacturing, and commercial.
Proactively monitor and report on ad hoc material supply status, escalate and mitigate any issues or delays, and ensure alignment on new delivery expectations.
Draft, execute, and complete Custom Product Specification (CPS) for Cat A/B - all operational sections. Packaging requirements, stability requirements, QC requirements, feasibility, labeling, CoA requirements, and SMCs. Manages review of CPS with stakeholders and updates internal shared sheets. Reviews and approves workflows. Updates to procedures and relevant documentation to reflect new Customer requirements (e.g., labels).
Involved in internal process improvements, internal/customer audits/questionnaires (if and when applicable), and the custom supply squad to prioritize meeting ever-changing customer requirements.
Accountable for compliance-related queries and investigations from Customers/Commercial, CRs, NCRs, and other queries or inquiries from the commercial and Business team.
Operations Custom squad member, supporting the team to address custom business activities/tasks, KPIs, and goals to support custom product portfolio growth and improvements.
Responsible for drafting and updating Custom-related procedures (e.g., SOPs, WIs) to align with best practices and continuous improvement implementation.
Support Production Planning activities as needed or assigned.
Who you Are as an Ideal Candidate Qualifications and Education Requirements Bachelor's degree in Science (Biology, Life Sciences, or similar) or Business (Logistics, Operations, Supply Chain, Project Management).
5+ years Pharma or Diagnostics Industry/relevant industry experience.
Preferred Skills Demonstrated interpersonal skills to work effectively with cross-functional, cross-enterprise, cross-cultural teams in multiple locations.
Understanding of Operations, Manufacturing, Logistics, and Supply Chain.
Thorough working knowledge of relevant international ISO Standards (13485, 14971) and regulations (European medical devices directives) would be advantageous.
Advanced understanding of ERP system knowledge, especially SAP (preferred).
Foresight and ability to be innovative and find creative solutions to problems.
Demonstrated ability to perform multiple, fast-paced tasks.
Demonstrated ability to prioritize and perform workload effectively, with minimal supervision.
Additional Notes This position requires an individual with strong organizational and attention to detail skills. You must have initiative and be self-motivated to achieve. You must be able to work with a diverse team of managers and scientists. Other desirable attributes include accountability, flexibility, strong work ethic, and strategic thinking.
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