Aps Level 6 - Canberra, Australia - National Health Funding Body

National Health Funding Body

Verified Company

Canberra, Australia

3 weeks ago

Posted by:

Olivia Brown

beBee Recruiter

Description

Job Reference Number 23-MDPQDIV-19770

Classification APS Level 6

Job Title APS Level - GMP Clearance Operations Team Leader (Several
Positions)

Division Medical Devices and Product Quality Division

Branch Manufacturing Quality Branch

Section GMP Clearance Section

Applications open date Wednesday, 30 August 2023

Applications closing date Wednesday, 13 September 2023 at 11:30pm AEST

Location Fairbairn, ACT

Status Ongoing

Employment type Full-time

Salary Range $91,092 - $102,765

Contact Officer Name:
Rheannon McNeil / Amanda Du

Phone:
/

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 preemployment medical (where

required).

Providing evidence of qualifications.

Division Responsibilities
The Medical Device and Product Quality Division regulates 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
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 Principles (GMP) for

medicines, blood, tissue, and cellular therapy products and conducting product recalls for all

types of therapeutic goods. MQB also has responsibility for the quality of medicinal cannabis

products.

Section Responsibilities
The GMP Clearance Section engages with a wide range of stakeholders, including

international regulatory authorities through our inspection reliance framework. We

evaluate equivalency of overseas GMP standards with the Australian framework as well as

participating in various forums to engage with a broad range of stakeholders to support the

broader goals of the TGA.

the manufacture of therapeutic goods from overseas manufacturers. Desktop-based

overseas regulatory agencies along with a range of other types of documentation.

Additionally, the section is responsible for managing the wider inspection reliance

framework which includes collaborating and maintaining agreements with our international

regulatory partners.***
Key Responsibilities

Under limited supervision, this role is responsible for:

Supervising the operations of a team including setting work priorities, workflows to

ensure quality outputs and key performance indicators are met.

Providing high level technical support to the team relating to GMP clearance.
Managing staff, including providing coaching and feedback and managing

performance.

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 indepth interpretation of legislation and

technical guidance documents relevant to the regulation of manufacturers.

Participation in presubmission and preclearance meetings to advise prospective

applicants on GMP.

Managing enquires related to GMP Clearance and undertaking assessments of more

based GMP clearance issue and administrative name and address changes.

assurance of risks in assessing documentary evidence associated with GMP clearance

requirements and principles of best practice regulation.

Assisting in the identification and implementation of process improvements and

providing technical advice to a range of internal and external stakeholders.

Undertaking statistical analysis and providing details on the number, type, and kinds
Facilitating and contributing to innovative and strategic initiatives.
Undertake other duties as directed, commensurate to the classification level of the

position.

Key Capabilities