Product Quality Professional

1 week ago

Brisbane, Queensland, Australia beBeeSpecialist Full time $120,000 - $140,000
About Our Team

We are seeking a skilled Quality Specialist to join our Virginia site team.

This role plays a crucial part in ensuring the quality of products manufactured at our site, and you will be responsible for providing leadership in batch release, operational quality, deviations and complaints management.

You will review and approve batch-related documentation such as manufacturing formulas, instructions and specifications. Our products comprise listed and registered complementary medicines and a growth view for OTC products, with distribution locally in Australia and within the Asia Pacific region.

The position involves a high level of collaboration with key stakeholders across Manufacturing, Engineering, Supply Chain and Country Quality. Main responsibilities include:

  • Ensuring operations are performed in accordance with cGMP using our SOPs and within the validated state
  • Maintaining production processes and areas audit ready at all times
  • Managing Quality KPIs via department meetings and Quality Management Review
  • Fostering a culture of quality behaviours and continuous improvement aligned with cGMP
  • Being the first point of contact for issues that may result in changes or deviations from a validated system or process that may impact product quality or safety

Additional responsibilities include:

  • Ensuring work performed by Production and Engineering aligns with approved SOPs and GMP documentation
  • Identifying continuous improvement opportunities, potential risks, and cGMP deficiencies; working with Production and Engineering to implement improvements or corrective actions
  • Closing non-significant deviations in a timely manner; supporting investigations and actions to closure within lead-times
  • Supporting the business to maintain TGA license
  • Managing Product Technical Complaints and related investigations
  • Participating in internal and regulatory audits conducted by Quality and regulatory agencies

To succeed in this role, you will need:

  • A University degree qualified in Engineering, Pharmacy or a relevant science-related discipline
  • Ideal 6+ years' experience in a cGMP regulated environment in FMCG, Consumer Healthcare or Pharmaceutical Industry
  • Experience with TGA (or equivalent), PIC/s requirements knowledge
  • Exposure to Quality Assurance and Compliance, Batch release, investigations of deviations, CAPA closure, updating procedures

We offer a collaborative and inclusive culture where you can grow new skills and develop consumer brands with passion and creativity.

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