Supplier Quality Assurance Specialist

2 days ago

Singapore beBeeGMP Full time $90,000 - $110,000

Job Title: Supplier Quality Assurance Specialist

This role is pivotal in upholding the highest standards of quality within our supply chain management programs. We are seeking a highly skilled and experienced professional to perform quality assurance activities, including supplier qualification, periodic performance monitoring, supplier change notification, decommissioning, and establishing quality agreements with suppliers.

Key Responsibilities:

  • Perform supplier qualification activities, ensuring all relevant documents are completed through liaison with stakeholders and suppliers.
  • Liaise with affiliate sites personnel for qualified supplier information decks.
  • Lead/Support on-site audits at supplier sites, prepare audit agendas, and coordinate with suppliers for CAPA responses.
  • Draft Quality Agreements with new suppliers or review existing QAA for engaged suppliers by affiliate sites.
  • Conduct quality assessments based on company procedures to determine if suppliers can be qualified for GMP use.
  • Update qualified supplier lists.
  • Perform periodic performance monitoring, supplier change notification, and decommissioning of suppliers.
  • Assume other tasks assigned by leadership.

Required Skills & Qualifications:

  • CAPA
  • FDA
  • Quality Management
  • ISO
  • GMP
  • Procurement
  • Audits

About You:

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
  • At least 8 years of working 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.
  • Experience in leading audits is preferred.
  • Proficient in English listening, speaking, reading, and writing.
  • Skilled in Microsoft Word, Excel, PowerPoint, SAP, and TrackWise.

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