Compliance Specialist

7 days ago

Adelaide, South Australia beBeeQuality Full time $70,000 - $90,000

Job Overview

We are seeking a Quality Associate to join our team at our site in Adelaide. 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 permanent full-time position working 76 hours a fortnight, Monday to Friday plus reasonable overtime and maybe weekend if required.

Key Responsibilities:

  • Ensure all incidents, deviations and complaints are reported to the appropriate persons and registered in the QMS in a timely fashion.
  • 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
  • Conduct training for staff against 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.
  • Co-ordinate cytotoxic/Antibiotic residue monitoring of cleanrooms.

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.

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