Hybrid NMI & Material Qualification Specialist

PSC Biotech® Corporation; Dunboyne; Hybride; EUR 65 000 - 90 000; Plein temps

Résumé du poste

PSC Biotech Corporation is seeking a New Material Introduction specialist to evaluate, qualify and lifecycle-manage materials used on site. You will ensure materials meet regulatory, quality and safety requirements through testing, supplier qualification and cross-functional collaboration to support product integrity and patient safety.

The role is hybrid with on-site support required as needed, and involves coordinating with procurement, R&D, QA, and operations to drive successful material

Qualifications

• Bachelor’s degree in engineering, pharmacy or science related field.
• 4 years' experience in supply chain or technical roles related to new product introduction in pharma.
• Ability to coordinate with multiple stakeholders to develop process-based solutions.
• SAP systems knowledge (production execution modules).
• Strong MS Excel skills.

Responsabilités

• Manage 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 needs balancing safety, quality, and timely delivery.
• Serve as the primary interface for material suppliers, procurement, R&D, process engineering, QA, regulatory and operations for NMI projects.
• 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 to ensure value is created for the site.

Connaissances

Initiative

Stakeholder mgmt

SAP knowledge

Single-use materials

Vendor engagement

Communication

Collaboration

Continuous improvement

Excel

Learning mindset

Formation

Bachelor’s degree in engineering, pharmacy or science related field

Description du poste

PSC Biotech Corporation is seeking a New Material Introduction specialist to evaluate, qualify and lifecycle-manage materials used on site. You will ensure materials meet regulatory, quality and safety requirements through testing, supplier qualification and cross-functional collaboration to support product integrity and patient safety.

The role is hybrid with on-site support required as needed, and involves coordinating with procurement, R&D, QA, and operations to drive successful material