Pharma Quality Assurance Specialist

Healthcare Professionals Group; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

Healthcare Professionals Group is seeking a hands-on Quality Assurance professional to support day-to-day QC activities across pharmaceutical storage and distribution operations.

You will contribute to product release, temperature excursions investigations, customer complaints and quality investigations, while supporting audits and CAPAs and driving continuous improvement with internal teams and external partners.

Qualifications

• Must have tertiary technical qualification or equivalent practical experience.
• Demonstrated experience in the pharmaceutical industry.
• Experience with GDP and GMP quality management systems.
• Ability to build cross-functional relationships.
• Able to work independently and collaboratively with flexible priorities.

Responsibilities

• Review and approve product release for distribution, ensuring quality standards.
• Investigate temperature excursions and assess impact on product quality.
• Manage customer complaints and returned product assessments with investigations.
• Prepare quality reports and performance metrics highlighting trends and risks.
• Support quality risk assessments, deviations, root cause analysis and CAPAs.
• Maintain training records and support GDP, GMP training.
• Participate in internal/external audits and follow up on findings.
• Review approvals and coordinate reapprovals for customers/vendors.
• Support change control, recall management and other quality improvements.

Skills

Technical discipline education

Pharmaceutical industry experience

GDP/GMP quality systems experience

Relationship building across functions

Independent and collaborative work

Education

Tertiary qualification in technical discipline

Job description

Healthcare Professionals Group is seeking a hands-on Quality Assurance professional to support day-to-day QC activities across pharmaceutical storage and distribution operations.

You will contribute to product release, temperature excursions investigations, customer complaints and quality investigations, while supporting audits and CAPAs and driving continuous improvement with internal teams and external partners.