APS Level 6
Vor 4 Tagen
The GMP Assessor 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 a wide range of stakeholders, including 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. If you want to be part of a team who support the supply of medicinal products in Australia, we want to hear from you.
The key duties of the position include:
Under limited supervision, this role is responsible for:
• Undertaking desk top based compliance verification/technical review of sterile and non- sterile medicine (including biotech) and/or API manufacturers.
• Liaising with international regulators and assessing equivalency against Australian framework to establish and maintain inspection reliance, where required.
• Applying sound decision making and judgement, including quality assurance of risks in assessing documentary evidence associated with GMP clearance applications, inspection reliance assessment and related enquiries in accordance with applicable regulatory requirements and principles of best practice regulation.
• Initiating, establishing, and maintaining strong relationships with a broad range of stakeholders and exercising high level consultation skills to effectively liaise with Australian sponsors, overseas regulators, overseas manufacturers (when required), and other teams within the TGA.
• Providing accurate specialist advice and in-depth interpretation of legislation and technical guidance documents relevant to the regulation of manufacturers.
• Undertaking statistical analysis and providing details on the number, type, and kinds of applications received/processed and assessments performed, where required.
• Undertake other duties as directed, commensurate to the classification level of the position.
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