New Material Introduction & Material Qualification Specialist

New Material Introduction & Material Qualification Specialist

Dunboyne, Ireland Posted on 10/22/2026

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dunboyne
• State/Province Meath
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

The New Material Introduction & MaterialQualification Specialist will be responsible for the evaluation, qualificationand lifecycle management of materials used in site. You will ensure new andexisting materials meet regulatory, quality and safety requirements throughrigorous testing, supplier qualification and cross functional collaboration,enabling reliable, compliant and cost effective supply to support productintegrity and patient safety.

Requirements

Key Accountabilities

• Responsible for managing CC (change controls) and driveresolution of gaps arising from SCN (supplier change notifications) submittedby vendors.
  
• Lead end-to-end new material introduction (NMI)activities, from technical evaluation and supplier qualification
  
• Plan, coordinate and execute material qualification toensure new materials comply with industry regulations, safety standards andproduct specific requirements
  
• Generate and review technical documentation required formaterial approval
  
• Ensure new materials are introduce on site to enablesuccessful 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 forNMI projects
  
• Responsible for materials introduction and qualificationprocess. Work with partners to manage these activities and refine the processesin alignment with regulatory & company procedures and support regulatoryand company compliance audits
  
• Maintain and update the approved materials list,qualified materials database
  
• Drive root-cause corrective actions and preventivemeasures for recurring material issues; lead cross-functional continuousimprovement projects
  
• Continuously Improve the NMI & MQ Process on site
  
• Build an excellent relationship with suppliers assignedto ensure value is created and delivered for the site
  

Preferred experience:

• Bachelor's degree in engineering, pharmacy or sciencerelated field.
  
• 4 Years previous experience within a Supply Chain ortechnical role associated with new product introduction in a pharmaceuticalenvironment.
  
• Sense of initiative and urgency, ability to work withmultiple stakeholders to develop process-based solutions and manage theassociated communications effectively.
  
• SAP systems knowledge- master data, production executionmodules.
  
• Strong knowledge of single use materials and applicableregulatory standards for the qualification of single use materials.
  
• Previous experience with engagement with vendors onmaterial related issues including supply chain notifications andinvestigations.
  
• Effective communicator to manage both internal andexternal stakeholders that support the site
  
• Collaboration skills and teamwork mindset
  
• Enterprise mindset to ensure the right priorities are setfor 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 continuousimprovement mindset
  

Other Job Requirements

• This role is a hybrid role; onsite support will berequired based on day-to-day activities