Validation Manager – Radiopharmaceuticals (The position has been filled)
Australia, New South Wales
Full Time
20/09/2019
  • Goverment TGA-Licensed Manufacturing Facility
  • Manage all Validation Activities & Prove your Worth
  • Work-Life Balance including Onsite Parking and Swimming Pool

 

THE CLIENT

Our client is a world-class government facility which manufactures a range of radiopharmaceuticals that are used as diagnostic and therapeutic agents. Some of these medicines 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 facility’s validation activities are compliant with the Australian code of GMP for medicinal products and meet TGA and ARPANSA licencing requirements.

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 Validation Manager’s role is accountable for the overarching framework for validation across this facility.

The successful candidate will safeguard the organisation by developing and implementing the overall plan and schedule for validation programs such as equipment & utilities qualification, process validation, cleaning validation, computerised systems validation, revalidation programs, method validation and shipping validation.

The Validation Manager will prepare the Validation Master Plan and associated work schedules and report on the progress of this plan ensuring compliance with TGA and ARPANSA licences, and other regulatory requirements as required (e.g. FDA)

You will also be responsible for leading process improvements in validation practices and is significant in influencing others and managing key stakeholder relationships.

 

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 Science or Engineering
  • Experience in a pharmaceutical environment is essential, ideally with experience in a highly regulated sterile manufacturing environment.
  • Extensive validation experience
  • Well-developed project management skills with the ability to initiate, manage, co-ordinate and meet objectives within scope, time and budget
  • Experience in TGA, FDA, ARPANSA, ASNO and ISO audits highly regarded
  • Experience in statistical analysis using tools such as JMP, SAP XL, Minitab etc.
  • Effective leadership, communication and influence skills
  • Teamwork skills including working in cross functional and multi discipline teams
  • Proven project management and technical report writing skills required

 

APPLICATIONS

To have a confidential discussion about this role please call our Head Office on 03 9516 0100. 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.

If on this occasion you’re unsuccessful, your details will be added to our Talent Pool database.