Quality Assurance Specialist

4 days ago


Singapore beBeeSupplier Full time $800,000 - $1,000,000
Quality Assurance Specialist - Supplier Management

This role plays a crucial part in supporting supplier management programs, encompassing quality activities such as supplier qualification, periodic performance monitoring, supplier change notification, and decommissioning. Our team is seeking a skilled Quality Assurance Specialist to lead supplier qualification initiatives, establish quality agreements with suppliers, and perform on-site audits.

Key Responsibilities:

  • Perform thorough supplier qualification activities, collaborating with stakeholders and suppliers to ensure relevant documents are completed and reviewed.
  • Liaise with affiliate sites personnel for qualified supplier information decks and assess the leverage of supplier qualification documents.
  • Lead on-site audits at supplier sites, preparing audit agendas, reports, and coordinating CAPA responses to close audit observations.
  • Draft quality agreements with new suppliers or review existing QAA for engaged suppliers.
  • Conduct quality assessments based on company procedures to determine if suppliers can be qualified for GMP use.
  • Update qualified supplier lists and perform periodic performance monitoring, supplier change notifications, and decommissioning.
  • Support leadership in other tasks assigned.

About You:

  • Bachelor's degree in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or a related field.
  • At least 8 years of experience in production and/or quality management, with a minimum of 5 years in supplier qualification QA.
  • Familiarity with FDA, EMEA, HSA, and PIC/S GMP requirements.
  • Leadership experience in audits is preferred.
  • Excellent English listening, speaking, reading, and writing skills.
  • Proficiency in Microsoft Word, Excel, PowerPoint, SAP, TrackWise, and effective communication.


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