Supply Chain Specialist

Aphex Group; Dunboyne; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Aphex Group in Ireland seeks a New Material Introduction & Material Qualification Specialist to evaluate, qualify and manage materials for site operations, ensuring regulatory and safety compliance and cost-effective supply to support patient safety.

You will drive supplier qualification, CC management, and cross-functional collaboration with QA, regulatory, R&D and operations to maintain an excellent materials lifecycle and site performance.

Qualifications

• Bachelor's degree in engineering, pharmacy or science related field.
• 2+ years experience in Supply Chain or technical role related to new product introduction in pharma.
• Sense of initiative and urgency; ability to coordinate with multiple stakeholders.
• Knowledge of single-use materials and regulatory standards for qualification.
• Vendor engagement on material issues including SCN and investigations.
• Strong communication with internal and external stakeholders.
• Collaboration and teamwork mindset to drive site priorities.
• Proficient in MS Excel and general computing.
• Willingness for continuous learning and process improvement.
• Ability to challenge status quo with a continuous improvement mindset.

Responsibilities

• Manage change controls (CC) and drive resolution of gaps from supplier change notifications (SCN).
• Lead end-to-end new material introduction (NMI) activities from evaluation to supplier qualification.
• Plan, coordinate and execute material qualification to meet regulations and product requirements.
• Generate and review technical documents for material approval.
• Ensure new materials are introduced on site to meet schedules while balancing safety and quality.
• Interface with suppliers, procurement, R&D, process engineering, QA, regulatory and operations for NMI projects.
• Oversee materials introduction and qualification processes; align with regulatory/company procedures and audits.
• Maintain and update approved materials list and qualified materials database.
• Drive root-cause and preventive actions for material issues; lead cross-functional improvements.
• Continuously improve the NMI & MQ processes on site.
• Build strong relationships with suppliers to create value for the site.

Skills

Supplier qualification

NMI process

Regulatory compliance

Cross-functional collaboration

MS Excel

Education

Bachelor's degree in engineering

Bachelor's degree in pharmacy

Science related field

Tools

MS Office

Job description

Purpose

The New Material Introduction & Material Qualification Specialist 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.

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 introduced 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.

Preferred experience:

• Bachelor's degree in engineering, pharmacy or science related field.
• 2+ Years previous experience within a Supply Chain or technical role associated with new product introduction in a pharmaceutical environment.
• Sense of initiative and urgency, ability to work with multiple stakeholders to develop process-based solutions and manage the associated communications effectively.
• 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.
• Effective communicator to manage both internal and external stakeholders that support the site.
• Collaboration skills and teamwork mindset.
• Enterprise mindset to ensure the right priorities are set for the site.
• Computer literate with advanced skills in MS Office, especially Excel.
• Ability and willingness for continuous learning.
• Ability to challenge the status quo with a continuous improvement mindset.

This role is a hybrid role; onsite support will be required based on day-to-day activities