Quality Systems

2 weeks ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Roles & Responsibilities

This role supports supplier management programs, including performing quality activities such as supplier qualification, periodic performance monitoring, supplier change notification, decommissioning, establishing quality agreements with suppliers.

Responsibilities:

  • Perform supplier qualification activities such as liaising with stakeholders (manufacturing team, procurement team, QC etc.) and suppliers (manufacturers and distributors of supplies, outsourced service provider etc.) to ensure supplier questionnaires are completed with relevant documents (e.g. business license, ISO certificates etc.)
  • Liaise with affiliate sites personnel for qualified supplier information deck to assess on the leverage of supplier qualification documents.
  • Lead/Support on-site audit at supplier site (if necessary). Prepare audit agenda, audit report and coordinate with supplier for CAPA response to close of audit observations.
  • Draft Quality Agreement (QAA) with new suppliers or review existing QAA for existing suppliers engaged by affiliate sites
  • Perform quality assessment based on company procedures to determine if suppliers can be qualified for GMP use.
  • Update qualified supplier list.
  • Perform periodic performance monitoring, supplier change notification and decommissioning of supplier.
  • Perform other tasks assigned by leadership.

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.
  • Experience with biopharma commercial quality systems is preferred.
  • Proficient in English listening, speaking, reading, and writing.
  • Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise etc.
  • Strong learning ability.
  • Effective at cross-functional communication and collaboration.
Tell employers what skills you have

CAPA
FDA
Quality Management
ISO
GMP
Procurement
PowerPoint
SAP
Writing
Audits
Excel
Microsoft Word
Manufacturing
Audit

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