Quality Associate

3 days ago

Sydney, Australia Icon Group Full time

**Quality and Safety**

**Sydney**

**Contract or Temp**

**Slade Health**

**QUALITY ASSOCIATE - SLADE HEALTH, MT. KURING-GAI**
- State of the Art Facility - Successful and Expanding Company
- Supportive and Collaborative Team Environment
- 7 Month Contract Position - Mt Kuring-gai Location

**About Slade**:
Slade Health is a division of ICON Group. It is an innovative national sterile compounding service provider with TGA Licensed manufacturing facilities based in New South Wales, Victoria and Queensland. At Slade Health, we produce aseptically compounded pharmaceutical products such as chemotherapy drugs, analgesics and antibiotics for use by patients in hospitals.

**About the role**:
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 7 month contract position working 76 hours a fortnight Monday to Friday between the hours of 9 AM and 5.06 PM.

**Key Responsibilities**:

- 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
- Conducting and coordinating training on Quality procedures and requirements.

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.

**What we are looking for**:

- 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

**How to apply**:
**COVID Health Requirement

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