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Position Details
Reference Number 37889
Position Title Quality Officer (Snr Hospital Scientist) - F/T
Employment Status Permanent Full Time
Entity Sydney Local Health District
Geographical Location RPA
Award Classification Hospital Scientists (Medical Technologists) - Snr Scientific Off
Salary $80,558.00 - $85,572.00
Number of FTE 1.00
Purpose of Position

Responsible for the implementation and maintenance of a Quality Management System suitable for TGA accreditation of the Department of Cell and Molecular Therapies (CMT) at Royal Prince Alfred Hospital

 

A Senior Hospital Scientist with a background in Quality Asssurance is required for a new position in the Department of Cell & Molecular Therapies at RPA. This is an opportunity to be involved in the establishment and operation of a specialist department manufacturing clinical cell therapies based on cutting-edge science.

 

This position is Permanent Full Time and is classified as a Senior Scientific Officer.

Selection Criteria An appropriate degree from an approved University in a relevant discipline, or equivalent

Experience in a medical scientific laboratory environment with extensive experience in quality assurance of blood products, pharmaceuticals or medical devices

Sound knowledge of the requirements of Good Manufacturing Practice (GMP), International Standard Organisation (ISO), Therapeutic Goods Administration (TGA) and Office of the Gene Technology Regulator (OGTR), Risk Management principles of the processes used in CMT, and related international regulatory systems and conventions.

Experience in document control, audit procedure, risk analysis, root cause investigation and corrective and preventative action (CAPA) plans

Exceptional communication skills refined through educating and working with manufacturing staff and management.

Ability to determine when to escalate a problem for resolution.

Competence and the ability to work as part of a team, or independently as required.

Ability to participate in an out of hours and call back roster as required to facilitate compliance.
Contact Person Dr Janet Macpherson
Contact Number 0295154867
Closing Date 19/08/2011
Supporting Documents
Position Description click here to view
Application Guide click here to view