Job Reference Number 22-MDPQDIV-14043
Classification APS Level 6
Job Title GMP Assessor
Division Medical Devices and Product Quality Division
Branch Manufacturing Quality Branch
Section GMP Clearance Section
Location The position is Canberra based; however other locations may be

considered for exceptional candidates
Status Ongoing
Employment type Full-time
Salary Range $88,439 - $99,772 per annum
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.

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
Email: simone.hosmer@health.gov.au

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

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
The GMP Clearance Section has responsibility for application management and desktop-
based assessments of GMP clearance applications. The section also manages stakeholder
enquires related to the manufacture of therapeutic goods from overseas manufacturers.
Desktop-based assessment of clearance applications relies on GMP inspections performed
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
cover two core functions: application receipt and management; and the technical/desktop
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

• Applying sound decision making and judgement, including undertake quality

assurance of risks in assessing documentary evidence associated with GMP clearance
applications, inspection reliance assessment and related enquiries in accordance
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

of applications received/processed and assessments performed, where required

• 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,

decision making.

manufacture of therapeutic goods.

Application Response
Your application will be assessed on your ability to demonstrate that you possess, or have
the real potential to develop, the required skills, knowledge, experience, and qualifications
to perform the role. These requirements are based on the information provided to you as
part of the job advertisement, in line with the APS Work Level Standards.

Applicants are required to provide a statement of claims framed around the key duties and
key capabilities. Your statement of claims should be no more than one page in total with a
font no smaller than size 10. Applications that do not meet these requirements may not
be considered.

Work Environment Description
Responsibilities – As detailed in Section 28 of the Work Health and Safety Act 2011 while at
work, a worker must:

• Take reasonable care for his or her own health and safety
• Take reasonable care that his or her acts or omissions do not adversely affect the

is given by the person conducting the business or undertaking to allow the person to
comply with this Act

• Cooperate with any reasonable policy or procedure of the person conducting the

business or undertaking relating to health or safety at the workplace that has been
notified to workers

• Complete all WHS related induction and training
• Report all work related incidents and/or illnesses to the WHS Section
  

Description Requirement Additional Information

Administrative

1. Computer Use Yes

2. Generic screen based Yes

3. Sitting at desk Yes

4. Standing for long periods No

Manual Handling

5. Lifting 0-15kg No

6. Lifting 15 kg + No

7. Climbing No

Description Requirement Additional Information

8. Bending No

9. Squatting No

10. Reaching No

11. Push/pull No

12. Sequential Repetitive No
Movements in short period of time

13. Manual dexterity/manipulation No

Work Environment

14. Work with others towards Yes
shared goals in a team environment

15. Works in isolation from other Yes
staff (remote supervision)

16. Distance walking (ie: Large No
building or inter-building transit)

17. Works outdoors No

18.Works in a call centre No
environment

19. Works in a customer service No
environment

Tasks Involving

20. Exposure to chemicals No

21. Exposure to biological hazards No

22. Working at heights No

23. Requirement to wear personal No
protective equipment (PPE)

24. Requirement for full Colour No
vision

25. Work with energetics and No
explosives

26. Exposure to Petrol, Oil, Lubricant No
Products that may cause

Description Requirement Additional Information

dermatological conditions

27. Exposure to extreme No
temperatures

28. Confined spaces No

29. Exposure to Non-ionising No
radiation

30. Excessive Noise No

31. Low Lighting No

32. Dangerous Goods/ Equipment No

33. Exposure to airborne odours No

Travel

34. Frequent travel - Vehicle No

35. Frequent travel - Aeroplane No

36. Frequent travel - Seaborne No

Cyclic Workload

37. Peaks & Troughs Yes

38. Frequent Overtime No

39. Rostered Shift Work No