Vacancy Details

APS 5 GMP Evaluator

The MQL Section administers two schemes designed to assure the quality of veterinary medicines in the Australian marketplace and facilitate the export of Australian-made veterinary chemical products. Under the Manufacturers’ Licensing Scheme, Australian-based manufacturers are licensed and audited by third-party, APVMA-authorised auditors for compliance with the APVMA’s Manufacturing Principles and the relevant code(s) of Good Manufacturing Practice (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.

 

POSITION SUMMARY

Working under limited direction, the GMP Evaluator assesses 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 makes regulatory recommendations. 

GMP evaluators apply scientific processes, technical knowledge and understanding of GMP processes in evaluating various applications or reviewing audit reports.

This position is a security assessed position. The successful applicant will be required to undergo a security assessment to obtain a baseline clearance, and to maintain that level of clearance while in the role.

 

KNOWLEDGE, SKILLS AND ABILITIES

To be a strong contender for the role you will be a detail-oriented, process-driven person with the ability to:

  • Work under limited direction and collaboratively within the team
  • Help the MQL team to administer the APVMA’s GMP assessment schemes, related activities and projects carried out by the team
  • Be quality focused, preferably with experience in a GMP environment
  • Provide technical and administrative support  to colleagues and stakeholders, negotiate audit outcomes and timeframes with individual manufacturers and contribute to enforcement activities
  • 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 for the delegates
  • Have strong communication skills, including in the preparation of reports and guidelines. 

 

SELECTION CRITERIA

To be considered for these roles you will need: 

Essential:

  • The ability to obtain a baseline clearance, and to maintain that level of clearance while in the role;
  • Demonstrated high-level written and oral communication skills, including an ability to prepare and present complex reports of a high standard, and an ability to negotiate and liaise with stakeholders;
  • Demonstrated Quality Assurance, Research & Development and/or Manufacturing experience in an area related to human pharmaceuticals, veterinary pharmaceuticals or immunobiologicals;
  • Ability to solve problems, pay attention to detail, and make decisions based on sound science and risk analysis;
  • Demonstrate ability to work flexibly and to plan, organise and prioritise a demanding workload, and to communicate priorities within the team;
  • Ability to work with limited day to day supervision, managing a portfolio of tasks to meet deadlines and contribute to team goals; and
  • Willingness to abide by the APS Values, Code of Conduct and Employment Principles; and a demonstrated commitment to applying the principles and practices of WH&S, equity and diversity in the workplace.

Desirable:

  • Experience of auditing against a quality standard in any capacity will be highly regarded 
  • Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, or in project management.