Position summary
The Manufacturing Quality and Licensing (MQL) Section as part of the Registration Management Program ensures that all veterinary chemical products, manufactured in Australia or entering in to Australian market, meet required quality standards. This is achieved through delivery of Good Manufacturing Practice (GMP)-based compliance schemes that underpin and monitor the manufacture of veterinary chemical products.
The MQL Section administers two schemes designed to assure the quality of veterinary medicines in the Australian marketplace as well as facilitate the export of Australian-made veterinary chemical products. Under the Manufacturers’ Licensing Scheme, Australian-based manufacturers are audited by third-party, APVMA-authorised auditors for compliance with the APVMA’s Manufacturing Principles and the relevant code(s) of GMP. The Overseas GMP Scheme ensures that foreign manufacturers supplying veterinary medicines to Australian consumers comply with quality standards that are equivalent to those applying to veterinary chemical products manufactured in Australia.
The Assistant Director is required to make sound recommendation and decisions based on professional judgement, evaluating risks in the context of a complex regulatory environment. The incumbent of the position is also expected to build and maintain strong working relationships with internal and external stakeholders. They will remain quality-focused, and preferably hold experience in an audit environment (e.g. manufacture of pharmaceuticals or other chemicals, food supply chains, warehouses, NATA audits).
Core functions
The key functions and responsibilities of this position will include:
- work under limited direction and collaboratively with APVMA staff, industry and external reviewer agencies
- manage, coordinate and administer the APVMA’s GMP assessment schemes, related activities and projects carried out by the MQL Section
- provide technical and administrative advice on more complex matters to colleagues and stakeholders, negotiate audit outcomes and timeframes with individual manufacturers and contribute to enforcement activities
- manage, supervise and train functional and/or project team staff on a day-to-day basis
- assess licence applications, GMP certificates, audit reports and related documentary evidence for compliance with APVMA’s legislative and GMP requirements for manufacturers of veterinary chemical products and make regulatory recommendations and decisions in accordance with delegated authorities
- prepare reports and guidelines, and contribute to the development and implementation of ancillary support functions, including audit monitoring and quality
- plan and undertake research and/or development tasks, attend and conduct audits (as required) and actively contribute to strategic sectional planning and the maintenance and improvement of APVMA quality system processes and forms
Selection criteria
To be considered for this role you will need:
Essential:
- Appropriate tertiary qualifications in a scientific discipline, such as pharmaceutical science, medical or veterinary science, chemistry or other related fields
- Demonstrated knowledge of the manufacture and regulation of chemical products and an understanding of Good Manufacturing Practice (GMP)
- Highly developed planning and organisational skills, attention to detail, and the ability to work both as part of a team and independently under limited direction
- Comprehensive knowledge of, and experience in, auditing processes
- Demonstrated ability to develop strong working relationships with internal and external stakeholders, represent the organisation and liaise, influence and negotiate with staff from other sections
- Strong communication skills, including the ability to write technical reports, guidelines and work instructions, as well as communicate persuasively with a variety of internal and external stakeholders
- Staff management or supervisory experience, with demonstrated resilience and a commitment to build personal and team capability