Pharmaceutical Quality Specialist

6 days ago

Adelaide, South Australia beBeeQuality Full time $85,000 - $115,000
About the Role

As a key member of the Quality team, you will collaborate closely with Operations to ensure that our compounding centre adheres to regulatory and GMP requirements, guaranteeing the release of high-quality products.

Key Responsibilities:
  • Release of compounded batches.
  • Participation in non-conformances investigation and root cause analysis, supplier and customer complaints.
  • Contribution to risk assessment, change control, validation, internal audits, document reviews, CAPA, and recall activities.
  • Liaison with relevant stakeholders to complete action items related to the above.
  • Coordinating training on Quality procedures and requirements.

You will drive continuous improvement in Quality performance across the site and business by identifying areas for focus and implementing improvements to enhance compliance and efficiency, engaging stakeholders to promote the Quality culture.

About You:
  • Experience in GMP compliant pharmaceutical manufacturing environments.
  • Background in sterile compounding environments.
  • Desired experience with regulators of pharmaceutical manufacture (e.g. TGA).
  • Knowledge of continuous quality improvement.
  • Competency in common IT software (MS Word, MS Excel, MS Visio).
  • Strong time and task management skills.
  • Tertiary qualification in a Science or relevant discipline.

A successful person in this role is someone who can excel in a fast-paced environment where quality is paramount, demonstrating proactive approach, exceptional communication skills, strong leadership, and role modeling capabilities.

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