New Material Introduction & Material Qualification Specialist

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Overview:

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.

Requirements

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
  

Other Job Requirements

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