Aps Level 5

3 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **22-MDPQDIV-16163

**Classification **APS Level 5

**Job Title **Chemistry Analyst

**Division **Medical Devices and Product Quality Division

**Branch **Laboratories Branch

**Section **Chemistry Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$79,002 to $85,437

**Mandatory Qualifications **A degree in chemistry or a closely related science from an
Australian tertiary institution or a comparable overseas
qualification.***

**Contact Officer Name**:Sonia Taflaga
**Phone**:262896876

**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 is part of the Health Products Regulation

Group (HPRG) within the Health Department. The division monitors and tests medicines and

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

international therapeutic goods manufacturers meet specified standards. The Health

Product Regulation Group functions as the Therapeutic Goods Administration (TGA).

**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; provides scientific expertise to assess technical data for marketing authorisations;
provides scientific and expert advice to internal and external stakeholders including

industry, government and international agencies, and participates in the development of

standards and international collaborative activities.

**Section Responsibilities**

Chemistry section undertakes physical and chemical testing of medicines in response to

external complaints or alerts raised by regulatory areas within TGA. Targeted testing surveys

of medicines are conducted, as is the investigative testing of unregistered therapeutic goods

to support enforcement and compliance activities undertaken by the TGA. Expert scientific

and technical advice is provided to a range of stakeholders. Regional assistance is provided

through contract testing of quality assurance samples for the WHO and for Pacific Island

nations and Timor Leste. The Section also participates in monograph development work for

the International Pharmacopoeia (WHO) and for the British Pharmacopoeia. The work the

Chemistry Section undertakes is varied and challenging. A range of techniques are utilised to

examine therapeutic goods in order to inform and make decisions regarding the safety,

effectiveness, and legality of these goods.***

**Key Responsibilities**
- Conduct, analyse and report on testing of therapeutic goods to verify that they meet

required quality standards, to support investigations conducted in response to public

health and safety concerns and for the purposes of accreditation, standardisation

and international harmonisation***
- Draft laboratory reports documenting the results of testing for approval by testing or

project managers***
- Assist in the development of planned testing projects through undertaking literature

searches, selecting products for testing, and drafting product requests notices***
- Participate in the development of new testing methods and the establishment of

their reliability and validity***
- Prepare and maintain laboratory records of testing in line with quality system and

accreditation requirements and record data in the information management system,

ensuring the highest standards of accuracy and clarity***
- Contribute to the development of high quality, evidence-based testing manuals and

SOPs***
- Maintain current knowledge of new testing methods and tools and train and guide

new staff to develop their familiarity with testing methods and equipment used in

the laboratory***
- Exchange information with other work areas across and outside the HPRG including

negotiating timeframes for work completion***
- Undertake testing, calibration and maintenance of laboratory instruments and

equipment, and identify and resolve technical faults and contribute to the

identification of the laboratory’s future equipment needs***
- Contribute to the development and implementation of continuous improvement

activities within the section***

**Key Capabilities**
- Understands chemistry and associated analytica

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