Quality Associate - Sydney, Australia - Icon Group
Description
Quality and Safety
Sydney
Full Time
Slade Health
QUALITY ASSOCIATE - SLADE HEALTH, MT. KURING-GAI
- State of the Art Facility
- Successful and Expanding Company
- Supportive and Collaborative Team Environment
- Permanent Full-Time Position
- Mt Kuringgai Location
With facilities based in Queensland, Victoria, New South Wales and New Zealand, quality is embedded into every stage of the compounding process.
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 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 9AM and 5PM.
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 nonconformances, 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.
In addition, you will support the team with Environmental Monitoring activities and perform quality assessments quarantined incoming goods as required.
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
- Experience in a sterile compounding environment (desirable)
- Experience with regulators of pharmaceutical manufacture (eg TGA)
- Experience in continuous quality improvement
- Competency in 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
Excited to join us?
**COVID Health Requirement
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