Executive Level 1

2 weeks ago


Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-MDPQDIV-16401

**Classification **Executive Level 1

**Job Title **Good Manufacturing Practice (GMP) Inspector

**Division **Medical Devices and Product Quality Division

**Branch **Manufacturing Quality Branch

**Section **Inspections Section

**Location **Fairbairn ACT, Melbourne VIC, Parramatta NSW

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$108,680 - $123,951

**Mandatory Qualifications **A degree in chemistry/biochemistry, biology or other relevant
science from an Australian tertiary institution, or comparable
overseas qualifications.***

**Highly Desirable **- Experience in the manufacture or quality assurance/quality
**Experience **control of medicines, blood, tissues and cellular therapies
- Knowledge of Good Manufacturing Practice (GMP)

**Contact Officer Name**:Jenny Hantzinikolas
**Phone**:0402894545

**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**

The Inspections Section is responsible for the assessment of manufacturers of medicines

and blood, tissue and cellular therapies for compliance with applicable regulatory

requirements and product standards. These assessments are performed both as on-site

inspections at the manufacturers’ premises and off-site reviews of applicable

documentation. Inspectors assess key information to make a determination about the

manufacturer’s compliance with manufacturing quality requirements for compliance cases.

Inspectors also conduct targeted inspections in response to potential non-compliance with

manufacturing quality requirements.

**Key Responsibilities**
- Plan and lead inspections of establishments involved in the manufacture of therapeutic

goods to assess compliance against established standards.
- Lead the preparation of and prepare high quality reports that document inspections,

their findings and recommendations on the suitability of licensing.
- Contribute to the development of risk-based approaches to guide the Section’s

approach to inspections and compliance management.
- Conduct all work in accordance with standard operating procedures and within required

timeframes.

of manufacturers’ compliance with applicable regulatory requirements and product

standards.
- Based on an assessment of the risks posed by issues identified through inspection or

assessment activity, assess and advise on proposed interventions designed to resolve

safety risks and communicate compliance requirements to the relevant industry

representative.
- Undertake close-outs of inspections and prepare Post Inspection Letters (PILs)

confirming any deficiencies identified during the inspection.
- Manage or contribute to project work to develop or improve business processes,

practices, work area capability, policies, guidelines or technical resources.
- Contribute to the development of business improvement strategies.

**Key Capabilities**
- Demonstrated strong strategic, analytical and problem-solving skills.
- Strong interpersonal and communication skills and the ability to develop and maintain

effective working relationships with internal and external stakeholders.
- Demonstrated plan


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