Aps Level 5

3 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-MDPQDIV-19639
**Classification **APS Level 5
**Job Title **Recalls Officer
**Division **Medical Devices and Product Quality Division
**Branch **Manufacturing Quality Branch
**Section **Recalls Section
**Applications open date **Friday 18 August 2023
**Applications closing date **Sunday 3 September 2023
**Location **Canberra, ACT
**Status **Ongoing
**Employment type **Full-time
**Salary Range **$81,372 - $88,000
**Desirable Qualifications **Certificate or Diploma in business, health, or medical

administration.
**Contact Officer Name**:Molly Maish-Rusnak
**Phone**:(02) 6289 3888

**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 and 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) assists in the timely supply of therapeutic goods,
ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on
assessing manufacturers' compliance with Good Manufacturing Practice for medicines,
blood, tissues, and cellular therapy products and conducting product recalls for all types of
therapeutic goods. MQB also has responsibility for the quality requirements for medicinal
cannabis, psilocybin and MDMA products.

**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**:

- Undertake assessment and management of the ‘close-out’ process for the recalls of

therapeutic goods in accordance with the Uniform Recall Procedure for Therapeutic
Goods (URPTG).
- Maintain complete, auditable documentary evidence relating to the assessment of

recalls and their resulting actions.
- Liaise with a broad range of stakeholders and exercise negotiation and consultation

skills to effectively liaise with other TGA branches, manufacturers, and Australian
sponsors of therapeutic goods.
- Provide advice relevant to the recall actions of therapeutic goods to various

stakeholders, both internal and externally.
- Undertake review and finalisation of low-risk recall actions.
- Assist the APS 4 staff with entering new notifications, monitoring the group inbox

and general enquiry phone line, and any other administrative duties as required.
- Monitor international recall actions and other compliance signals or alerts and send

the necessary enquiry letters to Australian sponsors as required.
- Maintain and update the contact details for notified parties pursuant to the Uniform

Recall Procedure for Therapeutic Goods.
- Production of the weekly statistical report and other ad-hoc performance statistics

and KPIs as required.
- Undertake review and information gathering steps for Freedom of Information (FOI)

requests, Subpoenas, media enquiries, parliamentary questions, and other similar
requests.
- Provide assistance in relation to the review and updating of guidance documents as

required.

associated with notifications and related enquiries, consistent with applicable
regu

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