Quality Associate

Icon Group; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

Slade Health, part of Icon Group, seeks a Quality Associate at Mt Kuring-gai. You will join a fast-paced GMP pharmaceutical compounding environment supporting regulatory compliance and product quality.

Reporting to the Site Quality Manager, you will handle incidents, investigations, CAPA, audits, and staff training, with a focus on continuous quality improvement. This permanent full-time role offers 76 hours per fortnight, Monday to Friday, 9 am–5 pm, in a collaborative team committed to patient

Qualifications

• Experience in a GMP pharmaceutical manufacturing environment.
• Experience in sterile compounding.
• Experience with Quality Systems development and implementation.
• Regulatory exposure (eg TGA) in pharmaceutical manufacturing.
• Strong IT skills in MS Word, Excel and Visio.

Responsibilities

• Report incidents, deviations and complaints to the QMS promptly.
• Investigate non-conformances and perform root cause analysis.
• Draft customer complaint responses and monthly reports.
• Participate in risk assessment, change control, validation and audits.
• Train staff on Quality procedures and maintain records.
• Provide guidance on quality processes when requested.

Skills

GMP experience

Sterile compounding

Quality systems

Regulatory knowledge

Project management

Communication skills

Leadership

MS Office

Education

Science degree

Job description

• Progressive and Far-Reaching Career Opportunities


• Collaborative and Supportive Work Environment


• 9 AM - 5 PM Monday to Friday - Permanent Full-Time Position – Mt Kuring-gai Location

QUALITY ASSOCIATE – SLADE HEALTH, MT. KURING-GAI

Slade Health

Underpinned by 60 years’ experience, Slade Health is Australia’s leading chemotherapy compounding provider with a commitment to patient care, quality, innovation and integrity.

Slade delivers approximately 1.2 million infusions each year to over 200 hospitals across the public and private healthcare sector, including long-term state-wide government contracts. Slade operates five licensed manufacturing facilities - four in Australia and one in New Zealand, and under Icon Group has recently acquired BathASU (part of Pharmaxo Group) in the United Kingdom. [AM1]Slade Health is a full-service compounder providing antibiotics, chemotherapy, analgesics and theatre lines, and the exclusive compounder in Australia of Fresenius Kabi Total Parenteral Nutrition.

For more information visit https://sladehealth.com.au/;

The Opportunity

As an integral member of the Quality team, you will report to the Site Quality Manager and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP requirements ensuring that the products compounded are of the highest quality. This is a permanent full-time position working 76 hours a fortnight, Monday to Friday between the hours of 9 AM and 5 PM.

Key Responsibilities

• Ensure all incidents, deviations and complaints are reported to the appropriate persons and registered in the QMS in a timely fashion.


• Investigation and root cause analysis of non-conformances, supplier and customer complaints


• Writing of customer complaint responses and monthly reports


• Participating in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities


• Conduct training for staff against Quality procedures and requirements.


• Ensure training records are complete for all training against Quality procedures.


• Provide advice and guidance to staff regarding quality processes and procedures when requested.

About You

• Experience in a GMP compliant pharmaceutical manufacturing environment


• Experience in a sterile compounding environment


• Experience in development and application of Quality Systems


• Experience with regulators of pharmaceutical manufacture (eg TGA)


• Experience in continuous quality improvement


• Competencyin common IT software (MS Word, MS Excel, MS Visio)


• Competent in project, time and task management


• Tertiary qualification in a Science discipline (preferably including study in microbiology or chemistry

The successful candidate will thrive in a fast-paced environment where quality is paramount. You will have a proactive approach, exceptional communication skills and be a strong leader/role model.

In addition, you will 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.

Excited to join us?

Our team makes us who we are, they shape our impact and drive our success. Visit https://icongroup.global/en/careers/our-people/stories/ to read the stories of our incredible people. 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) including COVID-19. Certain roles may require the successful candidate to show evidence that they have been vaccinated against or are not susceptible to specified VPDs..