Aps Level 4

2 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-MDPQDIV-19250
**Classification **APS Level 4
**Job Title **Recalls Support Officer
**Division **Medical Devices and Product Quality Division
**Branch **Manufacturing Quality Branch
**Section **Recalls Section
**Applications open date **27 July 2023
**Applications closing date **13 August 2023
**Location **Fairbairn ACT
**Status **Ongoing
**Employment type **Full-time
**Salary Range **$75,917 to $80,215 per annum
**Desirable Qualifications **Certificate level qualifications, training or similar experience in

the use of Microsoft Office, electronic databases and document
management systems.

**Contact Officer Name**:Melissa Sorrentino
**Phone**:02 6289 1986

**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 a 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 Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health and Aged Care is responsible for safeguarding and enhancing the
health of the Australian community through the effective and timely administration of the
- Therapeutic Goods Act 1989_. The TGA applies a risk management approach designed to
ensure that therapeutic goods supplied in Australia meet acceptable standards of quality,
safety and efficacy (performance), when necessary. The work of the TGA is based on
consumers outweigh any risks associated with the use of therapeutic goods (including
medicines, vaccines, medical devices and biologicals).

The Medical Devices and Product Quality Division monitors medical devices approved for
supply in Australia and works to ensure Australian and international therapeutic goods
manufacturers meet specified standards.

**Branch Responsibilities**
The Manufacturing Quality Branch (MQB) works to ensure manufacturers of medicines, as
well as blood, tissue and cellular therapies, meet appropriate quality standards. This
involves both the physical and/or remote inspection of manufacturing facilities in Australia
and abroad; provision of clearances for facilities where suitable inspections have been
carried out by comparable overseas regulators; and, where necessary, initiation of
appropriate regulatory action to ensure compliance with the quality standards. The Branch
also coordinates product recall activities and provides technical advice to support decisions
made by the Medicines Regulation Division (MRD), particularly on matters relating to
manufacturing practice and quality management.

**Section Responsibilities**
The Recalls Section is responsible for coordinating and managing recall actions for defective
or unsafe therapeutic goods in Australia following the provisions of the Uniform Recall
Procedure for Therapeutic Goods (URPTG). This involves liaison with the sponsor/supplier of
the therapeutic good, relevant regulatory areas within the TGA and other external
stakeholders as required. Team members collect and collate information to make risk-based
assessments as part of their role in managing and coordinating recall and non-recall actions.
Recommendations are made to identify and implement appropriate responses or recall
activities. Post-implementation, recall activities are monitored for compliance and
effectiveness.***

**Key Responsibilities**:

- Triage/monitoring Recalls inbox and acting as the first point of contact, escalating if
- required to Recall Coordinators/ senior management.- Assist in performing the initial review of recall action close out reports from sponsors
- and escalate issues to senior staff when required.- Ad-hoc and routine operational Key Performance Indicator (KPI) reporting (statistical
- performance reports).- Collection of information regarding new recall notifications from external

stakeholders.
- Assist in the review of non-compliant, late or missing 2 and 6 week recall progress

reports.
- Contribute to the efficient and effective functioning of the Branch to assist the MQB

to meet its organisational objectives by undertaking other tasks as directed.
- Contribute to the Section’s commitment to adopting processes of continuous

improvement, through periodical process review activities.
- Maintain effective document control via the Branch’s Quality Management System.***

**Key Capabilities**:

- Broad based experience in providing administrative support, knowledge of Microsoft

Office products in particular Excel, Word and Outlook and experience using
electronic document management systems and databases (e.g. TRIM, eBS, Lotus
Notes).
- Excellent verbal and written c

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