QUALITY ASSOCIATE – RELEASING – SLADES HEALTH, WOODVILLE ADELAIDE – SA
As a member of the Quality team, you will report to the Quality Pharmacist Supervisor and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP requirements and that the products compounded are released to the highest quality. This is a permanent full-time position working a minimum of 76 hours a fortnight, Monday to Friday with some overtime and occasional weekend and public holiday shifts to support operations.
In addition to release responsibilities, you may 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. This means identifying key areas of focus and implementing improvements to raise compliance and efficiency and engaging with stakeholders to promote the Quality culture.
Key Responsibilities
* Releasing of compounded batches.
* Participate in investigation and root cause analysis of non-conformances, supplier and customer complaints.
* Participate in risk assessment, change control, validation, internal audits, document reviews, CAPA and recall activities.
* Liaise with relevant stakeholders to complete action items related to the above.
* Conduct and coordinate training on Quality procedures and requirements.
About You
* Experience in a GMP compliant pharmaceutical manufacturing environment.
* Experience in a sterile compounding environment.
* Experience with regulators of pharmaceutical manufacture (e.g. 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 or relevant discipline.
You will know that a successful person in this role is someone who can thrive in a fast‐paced environment where quality is paramount, whilst displaying a proactive approach, exceptional communication skills, strong leadership and role‐modeling capabilities.
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). 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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