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