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This is a rare opportunity to join an leading Australian Pharmaceutical Manufacturer. They are seeking a Senior QA Compliance Officer 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.
If you are interested and would like to learn more about this position, please reach out to me on d.mcdade@proclinical.com
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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