Quality Associate – Slade Health, Woodville
* State of the Art Facility – Successful and Expanding Company
* Supportive and Collaborative Team Environment
* Permanent Full‐Time Position - 9AM to 5PM, Monday to Friday – Woodville (Adelaide) SA Location
Slade Health provides a complete range of sterile compounding services, including Chemotherapy, Analgesics, Antibiotics and TPN compounding. With facilities based in Queensland, Victoria, New South Wales, South Australia and New Zealand, quality is embedded into every stage of the compounding process.
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 the products compounded are of the highest quality. This is a permanent full‐time position working 76 hours a fortnight, Monday to Friday plus reasonable overtime and, if required, weekend.
Key Responsibilities
* Ensure all incidents, deviations and complaints are reported to the appropriate persons and registered in the QMS in a timely fashion.
* Investigate and conduct root‐cause analysis of non‐conformances, supplier and customer complaints.
* Write customer complaint responses and monthly reports.
* Participate in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
* Conduct training for staff on 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.
* Maintain and organise the site micro laboratory.
* Coordinate cytotoxic/antibiotic residue monitoring of cleanrooms.
In addition, you will support the team with Environmental Monitoring activities and perform quality assessments of quarantined incoming goods as required. You will drive ongoing continuous improvement in Quality performance across the site and the business, identify key areas of focus and implement improvements to raise compliance and efficiency, 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 in development and application of Quality Systems.
* Experience with regulators of pharmaceutical manufacture (e.g., TGA).
* Experience in continuous quality improvement.
* Competency with main 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.
Icon Group celebrates diversity and is committed to creating an inclusive workplace for all employees. We encourage applications from all diverse backgrounds.
Pre‐employment Health Requirement: 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.
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