QA Specialist

2 days ago

Caloocan City, National Capital Region, Philippines beBeeQuality Full time A$90,000 - A$120,000
Job Overview

Southern Star Research is a trusted CRO offering world-class, high-quality full-service clinical trials across the Asia Pacific region.

Key Responsibilities:
  • Lead and manage daily vendor qualification operations within the QA team;
  • Oversee vendor selection, assessments, and qualifications—including coordination with external auditors;
  • Act as subject matter expert in internal forums and vendor-related meetings;
  • Build strong relationships with internal teams and external partners to support vendor use and management;
  • Contribute to the development of audit schedules, quality metrics, and reports;
  • Drive process improvement by reviewing and updating procedural documentation;
  • Support the strategic planning of vendor assurance initiatives; and
  • Perform any additional responsibilities as assigned.
Broad QA Activities:
  • Delivering compliance advice
  • Conducting internal and external audits
  • Supporting sponsor audits and inspections
  • Reviewing and improving QA processes;
Requirements:
  • Minimum 5 years' experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials. CRO experience is preferred;
  • Strong knowledge of CRO / Healthcare / Pharmaceutical Vendor Management Quality Assurance activities and understanding of vendor oversight strategies in regulated environments is essential;
  • Strong background in QA and GxP auditing, especially GCP is essential and experience across other GxP areas (GLP, GPvP, GMP, GDP) is advantageous;
  • Critical thinker with a proactive, solutions-focused mindset;
  • Ability to travel across the region if required; and
  • Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).
What We Offer:
  • An attractive remuneration package;
  • Genuine work-life balance
  • We value flexibility
  • Career stability and security

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

Equality of opportunity for all job applicants.

Only successful candidates will be contacted.

Company Overview:

A leading CRO in the Asia Pacific region offering world-class clinical trial services.

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