Quality Systems

3 days ago

Singapore NUSANTARA PRIME CONSULTING PTE LTD (Nusaprime) Full time

Quality Systems & Compliance Specialist (Pharma/Biotech)
This role supports supplier management programs, including performing quality activities such as supplier qualification, periodic performance monitoring, supplier change notification, decommissioning, and establishing quality agreements with suppliers.
Responsibilities
Perform supplier qualification activities by liaising with stakeholders (manufacturing team, procurement team, QC, etc.) and suppliers (manufacturers, distributors, outsourced service providers) to ensure completion of supplier questionnaires with relevant documents (e.g., business license, ISO certificates).
Liaise with affiliate site personnel to assess the qualified supplier information deck and leverage supplier qualification documents.
Lead/support on-site audits at supplier sites (if necessary). Prepare audit agenda, audit report, and coordinate CAPA responses to close audit observations.
Draft or review Quality Agreements (QAA) with new or existing suppliers engaged by affiliate sites.
Perform quality assessments based on company procedures to qualify suppliers for GMP use.
Update the qualified supplier list.
Conduct periodic performance monitoring, supplier change notifications, and decommissioning of suppliers.
Perform additional tasks as assigned by leadership.
About You
Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or related fields.
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.
Experience leading audits is preferred.
Experience with biopharma commercial quality systems is preferred.
Proficient in English (listening, speaking, reading, writing).
Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise, etc.
Strong learning ability.
Effective cross-functional communication and collaboration skills.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance
Industries: Business Consulting and Services
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