Company Overview

This is a rare opportunity to join an leading Australian Pharmaceutical Manufacturer. They are seeking a Senior QA Compliance Officer for a 4 month FT contract to ensure robust compliance with Australian cGMP standards and relevant international requirements. The position requires strong technical expertise and hands-on experience in both internal and external auditing, along with a proactive approach to quality system improvement.

Responsibilities include but are not limited to:

Drafting and reviewing SOPs, deviations, CAPAs, and investigation reports.

Leading GMP training and SOP sessions across departments.

Acting as lead auditor for both internal and external GMP audits (including contract manufacturers and labs).

Managing and tracking audit findings, CAPAs, and supplier-related quality issues.

Overseeing the GMP Agreement process and maintaining supplier approval documentation.

Ensuring the approved supplier database is current and accurate.

Coordinating TGA GMP Clearance processes for overseas suppliers.

Conducting and supporting Product Quality Complaint investigations.

Supporting continuous improvement initiatives within the QA Compliance function.

Liaising with multiple internal teams and external partners to uphold quality standards.

Upholding compliance with company policies, codes of conduct, and WHS obligations.

Requirements:

Minimum of 5+ years QA experience within the pharmaceutical industry (human pharma preferred).

Proven internal and external GMP auditing experience.

In-depth knowledge of technical/GMP agreements and supplier management.

Familiarity with GMP clearance and TGA regulatory expectations.

Strong documentation skills aligned with GMP standards.

Excellent communication and cross-functional collaboration abilities.