Quality Assurance Manager – Steriles (The position has been filled)
Australia, New South Wales
Full Time
19/09/2019
  • Unique Goverment TGA-Licensed Manufacturing Facility
  • Utilise your QA Experience in Sterile Manufacturing Environments
  • 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 Compliance & Quality Manager, the Quality Assurance Manager role shall provide leadership to a team of QA professionals—whose work ensures the facility operates in full compliance with TGA, FDA & ISO 9001 requirements.

Your core duties will be overseeing the release of radiochemical, radioisotope products, and services; ensuring all products are fit for their intended use and, by confirming all processes undertaken are deemed valid and verify GMP standards have been maintained.

You will also be required to provide up-to-date information to Senior Management on resolving any compliance issues that may arise in relation to products, services, systems, procedures, and/or training. Ultimately, as the subject matter expert, the Quality Assurance Manager has to be across any change in the regulatory environment related to GMP manufacturing of radiochemicals and radiopharmaceuticals.

Hence, any prior management experience within the pharmaceutical industry combined with a strong knowledge of regulations will be highly regarded.

 

REQUIREMENTS

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

  • Minimum of a Bachelor degree qualification in Chemistry and/or Microbiology or related science;
  • Prior experience working within a highly regulated environment in the pharmaceutical industry;
  • Experience in sterile manufacturing; 
  • Several years’ experience in a senior quality assurance role that includes having responsibility for maintaining a quality management system, which complied with strict regulatory requirements;
  • Capability to lead a QA team undertaking compliance activities associated with TGA, FDA, ARPANSA, ASNO and ISO requirements, as well as liaising with external auditors; and
  • Working knowledge of GMP & TGA requirements, which extends to the International Pharmacopoeia, and a thorough understanding of ISO 9000 series standards.

 

APPLICATIONS

To have a confidential discussion about this role please call Helen or Jo on the following numbers:

Head Office: 03 9516 0100 (9 am to 5.30 pm, Mon.–Fri.)

After Hours: 0438 620 434 (Helen) / 0411 197 171 (Jo)

To apply, click the “Apply Now” button to submit your resume and also a brief covering letter addressing the above selection criteria.

Subsequently, as part of CS Executive Group’s pre-screening process for its clients, candidates who are considered suitable for shortlisting may then be sent formal selection criteria to respond to in more detail.

 

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.