NMI & MQ Specialist TPM6137

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

Summary:

A New Material Introduction & Material Qualification (NMI & MQ) Specialist is required for our client, a biopharmaceutical company in Meath. The successful candidate will evaluate, qualify and manage the lifecycle of materials used on site, ensuring they meet regulatory, quality and safety requirements. The role involves testing, supplier qualification and cross-functional collaboration to support reliable, compliant and cost-effective supply, product integrity and patient safety.

Responsibilities:

• Manage change controls and resolve gaps arising from supplier change notifications.
• Lead end-to-end new material introduction activities, including technical evaluation and supplier qualification.
• Plan, coordinate and execute material qualification to ensure compliance with industry regulations, safety standards and product-specific requirements.
• Generate and review technical documentation required for material approval.
• Coordinate the introduction and release of new materials to meet site schedules while maintaining safety and quality standards.
• Act as the primary contact for material suppliers, Procurement, R&D, Process Engineering, Quality Assurance, Regulatory and Operations teams on NMI projects.
• Manage material introduction and qualification processes with internal and external partners, ensuring alignment with regulatory requirements and company procedures, and support compliance audits.
• Maintain the approved materials list and qualified materials database.
• Lead root cause investigations, corrective and preventive actions for recurring material issues, and cross-functional continuous improvement projects.
• Continuously improve site new material introduction and material qualification processes.
• Build strong relationships with assigned suppliers to deliver value for the site

Qualifications & Experience:

• Bachelor’s degree in Engineering, Pharmacy or a related science discipline is required.
• Minimum of 2 years’ experience in a supply chain or technical role associated with new product introduction in a pharmaceutical environment.
• Knowledge of SAP master data and production execution modules.
• Strong knowledge of single-use materials and the regulatory standards applicable to their qualification.
• Experience working with vendors on material-related issues, including supply chain notifications and investigations.
• Advanced Microsoft Office skills, particularly Excel.
• Commitment to continuous learning and the ability to challenge existing practices to drive improvement.