Aps Level 6

**Job Reference Number **22-MDPQDIV-14721

**Classification **APS Level 6

**Job Title **Licensing Officer

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **Licensing and Compliance Strategy Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

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

**Mandatory Experience **- Experience working in a regulatory environment or in the
manufacture of medicines, such as regulatory affairs,

quality assurance or a role within a GMP setting.

**Desirable Qualifications **- A tertiary qualification in science such as chemistry,
biochemistry, microbiology, biotechnology, pharmacy or
engineering from an Australian tertiary institute or
equivalent overseas qualification.

**Contact Officer Name**:Scott Pearce
**Phone**:02 6289 2293

**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 responsible for undertaking

for supply in Australia. It is also responsible for the ongoing monitoring of medical devices to

ensure they meet the necessary standards throughout their lifecycle. The Division also

works to ensure Australian and international therapeutic goods manufacturers meet

specified standards and provide laboratory services.

**Branch Responsibilities**

The Manufacturing Quality Branch (MQB) is responsible for ensuring manufacturers of

medicines as well as blood and biologicals, meet appropriate quality standards. This involves

both the physical inspection of manufacturing facilities in Australia and abroad as well as

provision of clearances for facilities where suitable inspections have been carried out by

comparable overseas regulators. The branch also coordinates product recalls when

necessary and provides technical advice to support Medicines Regulation Divisions

decisions, particularly on matters relating to manufacturing practice and quality

management.

**Section Responsibilities**

The Licensing and Compliance Strategy Section has responsibility for the licensing and GMP

management, scheduling on-site inspections, travel security assessments, arranging

domestic and international travel, invoicing/cost recovery, responding to general and

technical GMP enquiries, liaising with overseas regulatory agencies and the identification

and assessment of GMP compliance signals related to manufacturers of medicines supplied

in Australia.

**Key Responsibilities**
- Initiating, establishing and maintaining strong relationships with a broad range of

stakeholders and exercising high level consultation skills to effectively liaise with TGA

inspectors, manufacturers and Australian sponsors of therapeutic goods.
- Undertaking activities related to the scheduling of GMP inspections including

inspections; and managing the processes to ensure any changes to inspections are

responded to, to ensure mínimal impact to the schedule and performance targets.
- Liaising with other sections and branches within the TGA as well as International

regulatory agencies in relation to GMP inspections.
- Undertaking statistical analysis and reporting as required.
- Managing a group mailbox, including actioning and delegating tasks in timely

manner and provide accurate advice and proposals are required.
- Facilitating and contributing to innovative and strategic initiatives. Assisting in the

identification and implementation of process improvements and providing technical

advice to a range of internal and external stakeholders.***

**Key Capabilities**
- High level communication skills and an ability to liaise engage and collaborate with a

diverse range of internal and external stakeholders to achieve outcomes and

facilitate cooperation for operational and strategic initiatives.
- Proven ability to make high impact decisions based on sound professional judgement

and evaluating and managing risks.
- Proven experience in working with considerable independence, including providing

feedback, monitoring performance and building staff capability.
- Excellent knowledge and experience in the regulation and/or manufacture of

therapeutic goods.
- Ability to contribute to business improvement/ change initiatives and strategies.

**Minimum Requirements**

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