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Sterile Compounding Quality Assurance Specialist
2 months ago
About Slade Health
Slade Health is a renowned national sterile compounding service provider with TGA accredited manufacturing facilities based in Victoria, Queensland, New South Wales, South Australia and New Zealand. With over 50 years of experience, we have established ourselves as a trusted industry name producing aseptically compounded pharmaceutical products such as chemotherapy drugs for use by patients in hospitals.
About the Role
We are seeking an experienced Sterile Compounding Quality Assurance Specialist to join our Quality team. As an integral member, you will report to the Quality Pharmacist Supervisor and site Quality Manager and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP requirements. This is a fantastic opportunity to expand your current skill set and support the Quality processes we have in place.
This permanent full-time position offers a competitive salary of $85,000 - $100,000 per annum, depending on experience. The successful candidate will be working a minimum of 76 hours a fortnight from 9:54am to 6pm, Monday to Friday (Shift times may vary depending on roster).
Key Responsibilities
- Releasing of compounded batches.
- Participating 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.
What We Are Looking For
- 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 discipline.
The ideal candidate will possess a can-do and patient-centric attitude, strong work ethic and great communication and influencing skills to build fruitful relationships within the business. If you think you have the skills we are looking for, please apply with a covering letter and resume.
