
Senior Manufacturing Quality Specialist
2 days ago
Good Manufacturing Practice (GMP) Inspector
About the Role:The Department of Health regulates and monitors the quality of therapeutic goods in Australia.
This involves both on-site and remote inspections of manufacturing facilities, as well as provision of clearances for facilities where suitable inspections have been carried out by comparable overseas regulators.
The team also coordinates product recalls when necessary and provides technical advice to support decisions made by the regulatory division, particularly on matters relating to manufacturing practice and quality management.
Key Responsibilities:- Plan and lead inspections of establishments involved in the manufacture of therapeutic goods to assess compliance against established standards.
- Prepare high-quality reports that document inspections, their findings and recommendations on the suitability of licensing.
- Contribute to the development of risk-based approaches to guide the team's approach to inspections and compliance management.
- Strategic and analytical thinking with strong problem-solving skills.
- Excellent interpersonal and communication skills with the ability to develop and maintain effective working relationships with stakeholders.
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