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Aps Level 6

3 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **22-MDPQDIV-15910

**Classification **APS Level 6

**Job Title **Recall Officer

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **Recalls Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

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

**Security Clearance **None***

**Working with Children and **No
**Vulnerable People Check**

**Mandatory Qualifications **A tertiary qualification in science or health, (e.g., pharmacy,
microbiology, biotechnology, medical science from an Australian
tertiary institution or an equivalent overseas qualification***

**Desirable Qualifications **None

**Contact Officer Name**:Sharon Bennett
**Phone**:02 62893572

**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 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
**- Supervise and manage APS 4 and 5 level staff performing their day-to-day work

activities of the Recalls Section including the mentoring, training and

development of APS 4 and 5 team members.
- Provide assistance to the Deputy Australian Recall Coordinators by coordinating

recall actions of therapeutic goods in Australia where there are established

deficiencies in the quality, efficacy, safety, presentation or performance of the

goods.
- Assess and manage the recalls of therapeutic goods in accordance with the

Uniform Recall Procedure for Therapeutic Goods (URPTG), maintaining complete,

auditable documentary evidence relating to the assessment and resulting

actions.
- Initiate, establish and maintain strong relationships with a wide range of internal

and external stakeholders, including other TGA branches, the sponsors and

manufacturers of therapeutic goods, health professionals and members of the

general public.
- Ability to exercise high level negotiation and consultation skills to effectively

liaise with and provide expert technical advice on recall actions to these internal

and external stakeholders.
- Work with a high