New Material Introduction & Material Qualification Specialist

Tandem Project Management Ltd.; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a New Material Introduction & Material Qualification Specialist for a biopharmaceutical client in Meath.

The role covers evaluating, qualifying and managing materials lifecycle to meet regulatory, quality and safety requirements on site.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy or related science required.
• Minimum of 2 years’ experience in a supply chain or technical role related to new product introduction in pharma.
• Knowledge of SAP master data and production execution modules.
• Strong knowledge of single-use materials and regulatory standards for 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 ability to challenge existing practices to drive improvement.

Responsibilities

• Manage change controls and resolve gaps 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 regulations and safety standards.
• Generate and review technical documentation for material approval.
• Coordinate introduction and release of new materials to meet site schedules with safety and quality.
• Act as primary contact for suppliers, Procurement, R&D, Process Engineering, QA, Regulatory and Operations on NMI projects.
• Maintain approved materials list and qualified materials database.
• Lead root cause investigations and CAPAs for material issues and cross-functional improvements.
• Continuously improve site NMIs and material qualification processes.
• Build strong relationships with suppliers to deliver value.

Skills

2 years' experience in supply chain/ N

SAP master data & production execution

single-use materials knowledge

vendor management

Continuous learning & improvement

Education

Bachelor’s degree in Engineering, Pharmacy or related science

Tools

Excel

Job description

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.