Aps Level 6

**Job Reference Number **22-MDPQDIV-14115

**Classification **APS Level 6

**Job Title **Evaluator

**Division **Medical Devices and Product Quality Division

**Branch **Laboratories Branch

**Section **Biomedicines Evaluation Section

**Location **Fairbairn, ACT - Melbourne, VIC (Outposting)

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$88,439 - $99,772

**Mandatory Qualifications **- A degree in a scientific field relevant to vaccines, biological
medicines, chemistry, pharmaceutical science, microbiology
or a related discipline, from an Australian tertiary institution,
or comparable overseas qualification is required.
- Post-graduate qualifications will be highly regarded

**Contact Officer Name**:Michelle Bausch
**Phone**:02 6289 3438

**IMPORTANT NOTE: A merit pool will be created from this process and may be used to fill**
**similar vacancies that may become available in the organisation within an 18-month**
**period from the time of advertising.**

**Eligibility**
- To be eligible for employment with the Department of Health and Aged Care

applicants must be an Australian citizen at the time an offer of employment is made
- An applicant’s suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:

- Satisfactory completion of an Australian Federal Police criminal history check,

and where relevant a Working with Children and Vulnerable People Check.
- Completion of a medical declaration and pre-employment medical (where

required).
- Providing evidence of qualifications.

**Division Responsibilities**

The Medical Devices and Product Quality Division (MDPQD) is part of the Health Products

Regulation Group (HPRG). The Division evaluates, monitors and tests the quality of

medicines and medical devices approved for supply in Australia, and works to ensure

Australian and international therapeutic goods manufacturers meet specified standards.

**Branch Responsibilities**

The Laboratories Branch is responsible for post market monitoring and compliance testing,

investigations and reviews, as well as market authorisation assessment for therapeutic

goods. The branch:

- Conducts laboratory testing in accordance with the laboratories testing program, lot

release.
- Provides scientific expertise to assess technical data for marketing authorisations.
- Provides scientific and expert advice to internal stakeholders, committees, government

etc.
- Participates in the development of standards and international collaborative activities.

The branch is divided into specific laboratory sections.

**Section Responsibilities**

The Biomedicines Evaluation Section (BES) conducts pre-market and post-market

evaluations to assess the manufacturing quality of all vaccines and other therapeutic

products, such as anti-venoms and toxins, approved for supply in Australia, as well as

products manufactured in and exported from Australia.

**Key Responsibilities**
- Undertaking timely, high quality, expert evaluations of scientific data, documents,

biological medicines and/or chemical medicines meet regulatory requirements and

professional quality standards in line with a risk-based approach to regulation.
- Making robust regulatory decisions, and/or recommendations based on scientific

evaluation of a submission, specifying how any deficiencies in submissions may be

addressed.
- Undertake peer-review of reports created by other team members and evaluators to

ensure regulatory and quality standards are consistently applied across the team.

Manage workflow to ensure timely delivery of tasks.
- Working flexibly in a high-pressure environment to achieve team goals and broader

organisational objectives.
- Contribute to the development of standards, guidance documents, standard operating

procedures and other scientific and business processes to support business

improvement activities.
- Liaise and collaborate with internal and external stakeholders to resolve complex and/or

sensitive issues in relation to compliance with legislation, regulations and standards

including representing the organisation at internal and external forums.
- Build team capability and contributing to business improvement and cultural change

initiatives.

**Key Capabilities**
- High-level analytical capability in a relevant scientific discipline and a capacity to

undertake objective, critical analysis and to provide expert advice on this basis.
- A sound understanding of the regulatory framework for therapeutic goods in Australia,

including applicable standards and guidelines, or demonstrated ability to rapidly learn
- The ability to lead, promote and make balanced decisions using professional judgement

and consideration of risks and context.
- High-level interpersonal, liaison and stakeholder management skills, including the ability

to develop productive working relationships to identify opportunities and facilitate

cooperation.
- The ability to wor