Aps Level 6

**Job Reference Number **23-MDPQDIV-16613

**Classification **APS Level 6

**Job Title **GMP Assessor

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **GMP Clearance Section

**Location **Fairbairn, ACT; Parramatta, NSW

**Status **Ongoing

**Employment type **Full-time

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

**Mandatory Qualifications **A tertiary qualification in a relevant field, e.g., chemistry,
biochemistry, microbiology, biotechnology, pharmacy or
engineering from an Australian tertiary institute or equivalent
overseas qualification.***

**Desirable Qualifications **Applicants who do not have a tertiary qualification in the above
fields, but with demonstrated knowledge and experience in the
manufacture of therapeutic goods, and/or experience working
in a regulatory environment relevant to the manufacture of
therapeutic goods may also be considered.

**Contact Officer Name**:Simone Hosmer
**Phone**:(02) 6289 1568

**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**

Regulate the quality of health products for the Australian community by:

- Assessing medical devices, including in vitro diagnostic tests
- Testing and monitoring medical devices and medicines to help ensure they continue

to meet appropriate levels of quality, safety, and performance
- Auditing and certifying manufacturers against manufacturing standards so the

products they produce meet appropriate quality, safety, and performance standards.

**Branch Responsibilities**

The Manufacturing Quality Branch 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 as

well as 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 recalls when necessary and provides technical advice

to support decisions made by the Medicines Regulation Division, particularly on matters

relating to manufacturing practice and quality management.

**Section Responsibilities**

enquires related to the manufacture of therapeutic goods from overseas manufacturers.

by comparable overseas regulatory agencies along with a range of other types of

documentation. Additionally, the section is responsible for managing the wider inspection

reliance framework. This includes collaboration, assessment, and maintenance with multiple

international regulatory agencies.

This diverse section is comprised of approximately twenty staff across three teams that

GMP clearance assessment. The section also contributes to the broader Branch

responsibilities through contributions to projects and participation in various stakeholder

forums.

**Key Responsibilities**

Under limited supervision, this role is responsible for:

- Undertaking desk top based compliance verification/technical review of sterile and

non-sterile medicine (including biotech) and/or Active Pharmaceutical Ingredient

(API) manufacturers
- Liaising with international regulators and assessing equivalency against Australian

framework to establish and maintain inspection reliance, where required***

assurance of risks in assessing documentary evidence associated with GMP clearance

with applicable regulatory requirements and principles of best practice regulation***
- Initiating, establishing, and maintaining strong relationships with a broad range of

stakeholders and exercising high level consultation skills to effectively liaise with

Australian sponsors, overseas regulators, overseas manufacturers (when required),

and other teams within the TGA***
- Providing accurate specialist advice and in-depth interpretation of legislation and

technical guidance documents relevant to the regulation of manufacturers***
- Undertaking statistical analysis and providing details on the number, type, and kinds
- Undertake other duties as directed, commensurate to the classification level of the

position.***

**Key Capabilities**
- Demonstrated knowledge and experience in the manufacture of therapeutic goods,

particularly biotech and/or sterile medicines

regulations and regulatory guidelines
- Well-dev