New Material Introduction & Material Qualification Specialist

Orion Group Life Sciences are currently recruiting a New Material Introduction & Material Qualification Specialist (Hybrid) on behalf of our Multinational Biopharmaceutical Client based in Co. Meath on an initial 11-Month contract with potential to extend.

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.

Key Accountabilities

• 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

 
Preferred experience:

• Bachelor’s degree in engineering, pharmacy or science related field.
• 4 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.
• SAP systems knowledge– master data, production execution modules.
• 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

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.