QA Consultant

5 days ago

Singapore PQE SINGAPORE PTE. LTD. Full time $60,000 - $80,000 per year

QA Consultant – Supplier Qualification & Audits

Other information:

Type of contract: fixed-term (6 months)

Years of exp: 3-5 yrs

Location: Tuas Area

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? PQE Group has been at the forefront of these industries since 1998 , with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas .

Due to our constant growth, we are looking for a QA Consultant – Supplier Qualification & Audits to support our projects in Singapore.

Main 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.
  • Review and approve supplier questionnaires, quality agreements (QAA), and related documentation.
  • Perform quality assessment based on company procedures to determine if supplier can be qualified for GMP use.
  • Assess supplier-related risks and ensure mitigation actions are defined and implemented.
  • Support incoming material qualification and supplier monitoring activities.
  • Participate in internal audits and support regulatory inspections regarding supplier compliance.
  • Manage supplier-related quality events, including deviations, CAPAs, and change controls.

About you:

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
  • 3-5 years in supplier qualification QA in pharmaceutical/biopharma industry
  • 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.
  • Fluent in English.

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