Aps Level 6

5 days ago

Sydney, Australia Australian Government - Department of Health Full time

APS Level 6
- $88,439 - $99,772
- Fairbairn, ACT; Sydney, NSW

The TGA is seeking APS Level 6 GMP Assessor to join our diverse section within the Manufacturing Quality Branch. The position plays a crucial role in the regulation of therapeutic goods in Australia by performing GMP assessments of overseas manufacturing sites to ensure medicinal products supplied to Australia are manufactured to international quality standards. These assessments are performed across the entire spectrum of medicinal products regulated by the TGA including Active Pharmaceutical Ingredients (APIs), vaccines, chemical and biological prescription medicines as well as over the counter and listed medicines. We engage with international regulatory authorities and evaluate equivalency of overseas GMP standards with Australian framework as well as participating in various forums and engage with a broad range of stakeholders to support the broader goals of the TGA. We are keen to hear from you if you:

- Hold a tertiary qualification in a relevant field from an Australian tertiary institute or equivalent overseas qualification; and/or
- Have demonstrated knowledge and experience in the manufacture of therapeutic goods
- Demonstrated experience working in a regulatory environment including regulatory affairs roles relevant to manufacture of therapeutic goods.

**Essential and desirable qualifications**:

- A tertiary qualification in a relevant field, e.g., chemistry, biochemistry, microbiology, biotechnology, pharmacy or engineering from an Australian tertiary institute or equivalent overseas qualification is essential.

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