Supply Chain Specialist - New Material Introduction & Material Qualification
Hybrid
RK26597
Contract 11 months
Meath
We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
This role will be responsible for the evaluation, qualification and lifecycle management of materials used in site. You will ensure new and existing materials meet regulatory, quality and safety requirements through rigorous testing, supplier qualification and cross functional collaboration, enabling reliable, compliant and cost effective supply to support product integrity and patient safety.
Key Responsibilities:
- Responsible for managing CC (change controls) and drive resolution of gaps arising from SCN (supplier change notifications) submitted by vendors.
- Lead end-to-end new material introduction (NMI) activities, from technical evaluation and supplier qualification
- Plan, coordinate and execute material qualification to ensure new materials comply with industry regulations, safety standards and product specific requirements
- Generate and review technical documentation required for material approval
- Ensure new materials are introduce on site to enable successful release to meet schedule need as well as balancing safety first, quality always
- Serve as the primary interface for material suppliers, procurement, R&D, process engineering, QA, regulatory and operations for NMI projects
- Responsible for materials introduction and qualification process. Work with partners to manage these activities and refine the processes in alignment with regulatory & company procedures and support regulatory and company compliance audits
- Maintain and update the approved materials list, qualified materials database
- Drive root-cause corrective actions and preventive measures for recurring material issues; lead cross-functional continuous improvement projects
- Continuously Improve the NMI & MQ Process on site
- Build an excellent relationship with suppliers assigned to ensure value is created and delivered for the site
Education and Experience:
- Bachelor’s degree in engineering, pharmacy or science related field.
- 2-4 Years previous experience within a Supply Chain or technical role associated with new product introduction in a pharmaceutical environment.
- Strong knowledge of single use materials and applicable regulatory standards for the qualification of single use materials.
- Previous experience with engagement with vendors on material related issues including supply chain notifications and investigations.