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Pharmaceutical Quality Specialist

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Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000
Key Role

We are seeking a dedicated Quality Assurance professional to join our team in Sydney. In this pivotal role, you will be responsible for a wide range of quality assurance activities, ensuring that all products supplied in Australia and New Zealand meet stringent local regulatory standards.

You will act as a key quality point of contact, liaising with internal teams, international manufacturing sites, and regulatory bodies. This role is critical in ensuring the timely supply of safe and effective products to our patients.

  • Release for Sale: Act as an Authorised Person for the final disposition of imported therapeutic goods, performing batch review and release for sale in Australia in accordance with regulatory requirements and local procedures.
  • GMP Compliance & Incident Management: Contribute to the investigation and resolution of GMP non-compliance issues, deviations, and out-of-specifications (OOS) results. Develop and implement effective Corrective and Preventive Actions (CAPAs).
  • TGA & Medsafe Liaison: Act as the primary quality liaison with the TGA and Medsafe regarding quality defects, GMP non-compliance, and other significant quality matters.
  • Product Quality Complaint (PQC) Management: Oversee the end-to-end PQC process, from intake and investigation to trend analysis and reporting, ensuring timely closure and communication with stakeholders.
  • Product Recalls: Manage and coordinate all aspects of local product recalls, from initiation and risk assessment to execution and reporting to regulatory authorities, ensuring compliance with Australian recall procedures.
  • Local Rework & Relabelling: Manage and provide quality oversight for any local rework, over-labelling, or repackaging activities performed by third-party logistics providers, ensuring full GMP compliance.
  • GMP Clearance Support: Collaborate with the Regulatory Affairs team to support GMP Clearance applications for overseas manufacturing sites, providing necessary quality documentation and technical assessments.
  • Product Quality Review (PQR) Oversight: Review Annual Product Quality Reviews (APRs/PQRs) provided by manufacturing sites, ensuring all local commitments and regulatory requirements are met, and summarizing key data and trends for local management.
  • Business & Project Support: Support key business requirements from a QA perspective by providing expert guidance on new product introductions, technical transfers, and other commercial projects to ensure seamless, compliant execution.
  • Quality Agreements & Supplier Management: Draft, review, and maintain GMP Technical Agreements with contract manufacturers, third-party logistics providers, and other GxP vendors.
  • Central Point of Contact: Serve as the focal point for internal and external QA discussions, providing expert guidance to Supply Chain, Regulatory Affairs, Medical, and Commercial teams, as well as to international quality counterparts and third-party partners.
  • Quality Management System (QMS): Support the maintenance and continuous improvement of the local QMS, including document control, change control, training, and self-inspection programs.
Qualifications and Experience
  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
  • A minimum of 2-3 years of experience in a Quality Assurance role within the pharmaceutical, biotechnology, or medical device industry in Australia.
  • Demonstrated experience as an Authorised Person for product release under the Australian Code of GMP for Medicinal Products (PIC/S Guide to GMP).
  • In-depth, practical knowledge of TGA regulations, the Therapeutic Goods Act 1989, and PIC/S GMP guidelines. Experience with Medsafe (NZ) regulations is highly advantageous.
  • Proven experience in managing quality deviations, complaints, and product recalls.
  • Direct experience in liaising with the TGA on quality and compliance matters.
  • Experience with GMP Clearance processes for overseas manufacturers.
Benefits
  • A competitive salary package including superannuation and a performance-based bonus.
  • An opportunity to work for a leading global pharmaceutical company with a strong local presence.
  • A supportive and collaborative team environment that values quality and integrity.
  • Professional development and career progression opportunities.
  • Flexible working arrangements and a focus on employee well-being.