Quality Associate Releaser

Icon Group; Sydney; On-site; AUD 85,000 - 110,000; Full time

Job summary

Icon Group’s Slade Health facility in Mount Kuring Gai, Sydney, NSW, is hiring a Quality Associate - Releaser. You will join the Quality team to ensure GMP-compliant sterile compounding and timely release of batches.

The role reports to the Quality Pharmacist Supervisor and interacts with Operations to maintain compliance and high-quality products.

Qualifications

• Experience in GMP-compliant pharmaceutical manufacturing.
• Experience in sterile compounding.
• Experience with regulators (eg TGA) desired.
• Experience in continuous quality improvement.
• Competency in MS Word, MS Excel, MS Visio.
• Time and task management.
• Tertiary qualification in a Science or relevant discipline.
• Good communication skills.

Responsibilities

• Releasing of compounded batches.
• Participate in investigation and root cause analysis of non-conformances, supplier and customer complaints.
• Participating in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
• Liaising with relevant stakeholders to complete action items related to the above.
• Conducting and coordinating training on Quality procedures and requirements.
• Support Environmental Monitoring activities and assess quarantined incoming goods as required.

Skills

GMP experience

Sterile compounding

Regulatory knowledge (TGA)

Continuous quality improvement

Time management

Leadership

Communication skills

Education

Tertiary qualification in Science or relevant discipline

Tools

MS Word

MS Excel

MS Visio

Job description

• Dynamic, Collaborative and Supportive Work Environment
• Progressive and Far-Reaching Career Opportunities - State of the Art Facility
• 12 Month Contract Position
• Shift hour 2 PM to 10 PM (subject to change per operations requirements)
• Monday to Friday and some weekends if required – Mount Kuring Gai (Sydney), NSW Location

QUALITY ASSOCIATE - RELEASER – SLADE HEALTH, MOUNT KURING GAI SYDNEY - NSW

• Dynamic, Collaborative and Supportive Work Environment
• Progressive and Far-Reaching Career Opportunities - State of the Art Facility
• 12 Month Contract Position
• Shift hour 2 PM to 10 PM (subject to change per operations requirements)
• Monday to Friday and some weekends if required – Mount Kuring Gai (Sydney), NSW Location

About Us:

Slade Health is a provider of sterile compounding services from its TGA licensed manufacturing facilities based in Queensland, New South Wales, Victoria, South Australia and New Zealand. As a well-established and respected industry name, Slade has been producing aseptically compounded pharmaceutical products including chemotherapy, analgesic, nutrition and antibiotic drugs for use by patients in hospitals for over 50 years.

Part of something bigger

Being part of Icon Group, Australia’s largest dedicated cancer care provider, with a global presence in Singapore, Mainland China, Hong Kong and New Zealand. The Group is built on a strong but simple vision – to deliver the best care possible, to as many people as possible, as close to home as possible.

Here’s why our people choose us

Purpose, at Pace:

We remain focused on continually expanding our services and making them accessible to more people across Australia and internationally.

Impact, at Scale:

We have a global reach and are growing every day. Here you’ll know your work is making a difference.

Connection, at Heart:

Our work isn’t easy but it’s extremely important. Our secret ingredient is our incredible, connected, and talented people. And their secret ingredient is each other.

Opportunity, at Hand:

We’re continually innovating. Every week brings changes, growth and new opportunities.

The Opportunity

As an integral member of the Quality team, you will report to the Quality Pharmacist Supervisor and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP requirements and that the products compounded are released to the highest quality. This is a fantastic opportunity to expand your current skill set and support the Quality processes we have in place. This is a permanent full-time position working a minimum of 76 hours a fortnight, Monday to Friday and some weekends, shifts may be changed to support operations.

Key Responsibilities

• Releasing of compounded batches.
• Participate in investigation and root cause analysis of non-conformances, supplier and customer complaints.
• Participating in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
• Liaising with relevant stakeholders to complete action items related to the above.
• Conducting and coordinating training on Quality procedures and requirements.

In addition, you may support the team with Environmental Monitoring activities and perform quality assessments quarantined incoming goods as required. You will drive ongoing continuous improvement in Quality performance across the site and the business. This means identifying key areas of focus and implementing improvements to raise compliance and efficiency and engaging with stakeholders to promote the Quality culture.

About You

• Experience in a GMP compliant pharmaceutical manufacturing environment
• Experienced in a sterile compounding environment
• Experience with regulators of pharmaceutical manufacture (eg TGA) desired
• Experience in continuous quality improvement
• Competency in common IT software (MS Word, MS Excel, MS Visio)
• Competent in time and task management
• Tertiary qualification in a Science or relevant discipline
• Good communication skills

You will know that a successful person in this role is someone who can thrive in a fast-paced environment where quality is paramount, whilst displaying a proactive approach, exceptional communication skills, strong leadership and role modelling capabilities.

Icon Group celebrates diversity and is committed to creating an inclusive workplace for all employees. We encourage applications from all diverse backgrounds.

Icon is committed to managing the risk of transmission of specified vaccine preventable diseases (VPDs). Certain roles may require the successful candidate to show evidence that they have been vaccinated against or are not susceptible to specified VPDs.