Position Summary
Complete Product Release and Support compliance and minor regulatory activities on site.
Position Responsibilities
* Support Site Inspection Readiness Program.
* Support Health Authority, audits and inspections commitment tracking, ensure on time completion and monitoring of CAPA effectiveness.
* Support quality audits of Site, Suppliers and Contractors.
* Support regulatory agency inspections and conduct risk assessment of regulatory agency observations.
* Support Management of Import permit process for Biological Materials.
* Approve Laboratory, Manufacturing and Packaging Master Batch Records.
* Product release in compliance with registration file.
* Raw Material and Printed Material release.
* Support completion of APRs to approved schedule.
* Support completion of assessments of customer complaints in ETS.
* Support maintenance and renewal of Import and in-vivo permits and preparation, submission and approval of applications for new permits for the import and use of raw materials and bulk antigens.
Organizational Relationships
* Site Manufacturing and Support Teams
* Site Leadership & Enabling Functions
* Cross functional teams within GMS & GMT
* External parties including suppliers & service providers
* Government regulatory agencies
Education And Experience
Bachelor's Degree in Science and experience in the Australian regulatory environment for animal vaccines (APVMA, Dept of Agriculture, OGTR & SSBA).
Technical Skills Requirements
* Proven Organisation skills
* Presentation skills
* Ability to work with regulators effectively to achieve business outcomes
* Understanding of quality control testing
* A proven ability to analyse, assess and deliver results for a given issue
* A demonstrated ability to work effectively and credibly with all levels of the manufacturing organisation
* A sound understanding of GMP as well as corporate and regulatory quality standards
* An understanding of large scale manufacturing
* Computer literacy in word processing, spreadsheet analysis, presentation software and database software
* Ability to navigate & operate virtual meetings in various platforms
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