QA Associate - Vendor Assurance

Aspen Pharmacare is one of Australia's leading pharmaceutical companies, dedicated to improving health and quality of life in the communities we serve through a diverse portfolio of prescription and over the counter medicines across a wide range of therapeutic areas. Since commencing operations in Australia in 2001, we have grown through strategic acquisitions and long term partnerships, building a strong local presence across Australia and New Zealand.

Our world class manufacturing facility in Dandenong South, Victoria, produces medicines and medical devices for local and export markets, with a strong focus on quality, reliability and compliance. Our values of Commitment, Excellence, Innovation, Integrity and Teamwork continue to guide everything we do.

We are currently recruiting for a QA Associate – Vendor Assurance to join our Quality Systems team based at Dandenong South.

Reporting to the Quality Systems Manager, you will play a key role in ensuring our vendors, raw materials and service providers meet Aspen's quality standards and regulatory requirements, supporting the manufacture and release of safe, high-quality medicines.

About the Role

As the Quality Associate – Vendor Assurance, you will support the effective delivery of Aspen's Vendor Assurance Program by assessing, approving and monitoring suppliers and service providers to ensure compliance with GMP requirements and company quality standards.

You will work collaboratively across Quality, Technical and Operations teams to identify and manage quality risks, maintain supplier approvals, and drive continuous improvement of our vendor assurance systems.

Key Responsibilities

Assess, approve and monitor suppliers of raw materials, packaging components and outsourced services.

Conduct supplier risk assessments and evaluate vendor suitability.

Participate in supplier audits, prepare audit reports and manage follow-up activities.

Develop and maintain Quality Agreements with suppliers and contract service providers.

Manage raw material qualification activities and supply chain risk assessments.

Perform quality risk assessments for drug products, including nitrosamine, allergen and TSE/BSE risk assessments.

Monitor supplier performance and maintain the Approved Supplier List.

Maintain supplier and material records within ETQ.

Identify opportunities to improve Vendor Assurance procedures and systems.

Contribute to the management of quality records, including deviations, change requests, CAPAs, reject notes and risk assessments, where relevant to vendor assurance activities and within the broader scope of the QA department.

Support compliance activities and contribute to continuous improvement initiatives within QA.

About You

To be successful in this role, you will have:

Tertiary qualifications in Science or a related discipline.

At least five years' experience within the pharmaceutical industry, ideally in QA, Quality Control or Compliance.

A sound understanding of cGMP requirements for medicinal products and APIs.

Knowledge of pharmaceutical raw materials and supplier qualification processes.

Strong written and verbal communication skills.

Excellent organisational skills with the ability to manage multiple priorities.

Proficiency in Microsoft Office applications.

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