Quality Assurance Specialist — Pharma (GDP/GMP)

Clinigen; Sydney; On-site; AUD 120,000 - 160,000; Full time

Job summary

Clinigen is seeking a Quality Assurance professional to lead QA functions for the Link ANZ warehouse facilities, ensuring GDP, GMP, ISO and local regulatory compliance across the site.

The role covers product release, complaint handling, investigations, CAPAs, quality metrics, training, audits, vendor management and risk management for ANZ operations. Collaboration with internal stakeholders is essential to drive continuous improvement and timely compliant product release.

Responsibilities

• Review and approve product release for distribution in accordance with GDP requirements and regulatory standards.
• Coordinate investigations with internal stakeholders, customers and manufacturers as required.
• Identify and implement corrective and preventive actions where appropriate.
• Prepare monthly quality reports and performance metrics for the ANZ business.
• Review and approve returned product assessments in accordance with GDP requirements.
• Investigate temperature excursions affecting medicinal products and assess impact.
• Support Quality Manager with risk management and escalation of issues.
• Gather data to support investigations and root-cause analysis of nonconformances.
• Drive training delivery on GDP, GMP, SOPs, and compliance procedures.
• Plan and participate in internal and external audits and manage audit findings and CAPAs.
• Maintain approved supplier lists and vendor oversight as part of QA duties.
• Organise and communicate quality information to stakeholders and ensure documentation is up to date.
• Ensure GDP compliance and alignment with regulatory guidelines across the site.

Job description

Clinigen is seeking a Quality Assurance professional to lead QA functions for the Link ANZ warehouse facilities, ensuring GDP, GMP, ISO and local regulatory compliance across the site.

The role covers product release, complaint handling, investigations, CAPAs, quality metrics, training, audits, vendor management and risk management for ANZ operations. Collaboration with internal stakeholders is essential to drive continuous improvement and timely compliant product release.