New Materials Introduction & Qualification Lead

Tandem Project Management Ltd.; Leinster; À distance; EUR 55 000 - 70 000; Plein temps

Résumé du poste

Tandem Project Management Ltd. seeks a NMI & MQ Specialist for a biopharmaceutical site in Meath. You will evaluate, qualify and manage materials throughout their lifecycle, ensuring regulatory, quality and safety compliance to support reliable supply and patient safety.

Responsibilities include leading material introduction projects, supplier qualification, change control management and cross-functional collaboration with R&D, QA and procurement. Strong knowledge of SAP and Excel is essential.

Qualifications

• Requires a degree in engineering, pharmacy or related science.
• Minimum 2 years in supply chain or tech role related to new product introduction in pharma.
• Familiarity with SAP master data and production execution modules.
• Knowledge of single-use materials and qualification standards.
• Experience coordinating with vendors on material issues and SC notifications.

Responsabilités

• Manage change controls and supplier-change notifications.
• Lead end-to-end new material introduction activities and supplier qualification.
• Plan and execute material qualification to ensure regulatory and safety compliance.
• Prepare and review technical documents for material approval.
• Coordinate introduction and release of new materials to meet site schedules.
• Serve as primary contact for suppliers, Procurement, R&D, Process Eng., QA, Regulatory and Operations.
• Oversee qualification processes with internal/external partners and audits.
• Maintain approved materials list and qualified materials database.
• Lead root cause investigations and CAPA for material issues.
• Drive continuous improvement of NMIs and material qualification processes.

Connaissances

SAP knowledge

Single-use materials knowledge

Vendor management

Excel proficiency

Continuous learning

Formation

Bachelor’s degree in Engineering, Pharmacy or related science

Outils

SAP

Excel

Description du poste

Tandem Project Management Ltd. seeks a NMI & MQ Specialist for a biopharmaceutical site in Meath. You will evaluate, qualify and manage materials throughout their lifecycle, ensuring regulatory, quality and safety compliance to support reliable supply and patient safety.

Responsibilities include leading material introduction projects, supplier qualification, change control management and cross-functional collaboration with R&D, QA and procurement. Strong knowledge of SAP and Excel is essential.