Quality Assurance Specialist: GMP/GDP Release & Compliance

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

Job summary

Clinigen Group is seeking a Quality Assurance professional responsible for product release, complaint management, and quality metrics in an ANZ context. You will liaise with internal stakeholders to resolve issues affecting release timelines and ensure regulatory compliance across GDP and GMP frameworks.

The role involves investigations, CAPA implementation and collaboration with suppliers and customers to uphold product quality and regulatory standards.

Qualifications

• Experience in pharmaceutical quality systems and GDP/GMP frameworks.
• Ability to identify and resolve quality issues and CAPAs.
• Experience with audits, deviations and investigation reporting.

Responsibilities

• Review product release for distribution and verify GDP compliance.
• Manage customer complaints, investigations and CAPAs as required.
• Prepare quality metrics and reports for management review.
• Handle returns and disposition decisions with supporting documentation.
• Coordinate internal and external audits and respond to findings.
• Assist in quality risk management and documentation control.

Skills

Stakeholder management

Quality assurance

Regulatory compliance

Audit & CAPA handling

Education

Tertiary qualification in technical discipline or relevant experience

Job description

Clinigen Group is seeking a Quality Assurance professional responsible for product release, complaint management, and quality metrics in an ANZ context. You will liaise with internal stakeholders to resolve issues affecting release timelines and ensure regulatory compliance across GDP and GMP frameworks.

The role involves investigations, CAPA implementation and collaboration with suppliers and customers to uphold product quality and regulatory standards.