Quality Assurance Associate (The position has been filled)
Australia, New South Wales
Full Time
10/02/2020
  • Unique Government TGA-Licensed Manufacturing Facility
  • Utilise Your Experience of GMP, ISO 9001 & TGA Requirements
  • Onsite Parking, Swimming Pool & Café

 

THE CLIENT

Our client is a world-class government facility which manufactures a range of nuclear medicines that are used as diagnostic and therapeutic agents. Some of these radiopharmaceuticals help medical practitioners make an accurate diagnosis of a patient’s illness whilst others are used therapeutically to treat diseased organs and/or tumours.

This government-run GMP facility’s medicines are validated in Australia by the Therapeutic Goods Administration (TGA) and in the US by the Food & Drug Administration (FDA).

Our client’s health products improve human health and save lives.

 

THE OPPORTUNITY

Based in a beautiful suburb, South-West of Sydney, this is a full-time ongoing position.

Reporting to the Quality Assurance Manager, the Quality Assurance Associate role shall contribute to ensuring the facility operates in full compliance with TGA, FDA & ISO 9001 requirements.

The role is an authorised position for Release for Supply—release of starting, intermediate, and finished radiopharmaceutical products—making certain all regulatory and customer obligations are met. Products released are fit for their intended use and, by confirming all processes undertaken are deemed valid, maintain GMP standards.

You will facilitate investigations arising from process/product deviations and recommend preventative actions for the future. And also be required to monitor quality-related trends, so as to provide the business with appropriate feedback.

Hence, it is essential you have experience within a manufacturing and/or pharmaceutical environment that includes participation in regulatory audits (e.g., TGA or FDA).

 

REQUIREMENTS

To be considered for this opportunity you must be willing to undergo appropriate federal government security and medical clearance. You shall also need to address the following criteria: –

  • Australian citizenship is essential;
  • Minimum of a Bachelor degree qualification in science or a related discipline;
  • Experience in quality systems for regulatory requirements, which includes performing and/or coordinating internal audits;
  • Experience in manufacturing and/or pharmaceutical environment that includes participation in regulatory audits (eg TGA or FDA)
  • An understanding of TGA, FDA, EU & ARPANSA requirements, as well as what is involved in demonstrating adherence to these regulations;
  • Sound knowledge and working understanding of GMP & ISO 9001, which extends to products covered by the International Pharmacopoeia(s);
  • Competence in computer literacy skills and a level of familiarity with electronic document management systems; and
  • Willingness to work extended and varied hours based on operational requirements, which shall necessitate undertaking short and infrequent periods of shift and/or after-hours work.

Given the nature of the facility, an appreciation of radiation safety considerations shall likely be considered advantageous.

 

APPLICATIONS

For a confidential discussion about this exciting opportunity please contact Dan on 0415 573 220.

Alternatively, if you would like to enquire electronically, please email [email protected]

In any communications relating to this opportunity, kindly cite the following job reference:

RADIOQA0220

To apply for this role, please click the ‘Apply Now‘ button then send your current resume and a covering letter to CS Executive Group.

 

THANK YOU

CS Executive Group would like to thank you in advance for taking the time to apply for this role. Unfortunately, due to the large volume of correspondence our recruitment team receives on a daily basis, we genuinely cannot respond to each application—only those applicants being considered for shortlisting as candidates are contacted.

However, if on this occasion you’re unsuccessful, please note your details will be added to our Talent Pool database.