Pharmaceutical Quality Assurance Specialist

17 hours ago

Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000
Quality Assurance Specialist

Sun Pharma is a leading global pharmaceutical company with a strong local presence in Australia and New Zealand. We are seeking an experienced and meticulous Quality Assurance Specialist to join our team.

The successful candidate will have the opportunity to contribute to the investigation and resolution of GMP non-compliance issues, deviations, and out-of-specifications results. They will also be responsible for developing and implementing effective Corrective and Preventive Actions (CAPAs).

In addition, the Quality Assurance Specialist will oversee the end-to-end Product Quality Complaint (PQC) process, from intake and investigation to trend analysis and reporting. This includes managing and coordinating all aspects of local product recalls, ensuring compliance with Australian recall procedures.

The ideal candidate will have a 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 is required.

Responsibilities:
  • 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 TGA requirements and local procedures.
  • Contribute to the investigation and resolution of GMP non-compliance issues, deviations, and out-of-specifications results.
  • Develop and implement effective CAPAs.
  • Oversee the PQC process, from intake and investigation to trend analysis and reporting.
  • Manage and coordinate all aspects of local product recalls.
  • Manage and provide quality oversight for any local rework, over-labelling, or repackaging activities performed by third-party logistics providers.
  • Collaborate with the Regulatory Affairs team to support TGA GMP Clearance applications for overseas manufacturing sites.
  • Review Annual Product Quality Reviews provided by manufacturing sites.
  • Support key business requirements from a QA perspective.
  • Draft, review, and maintain GMP Technical Agreements with contract manufacturers and other GxP vendors.
  • Provide expert guidance to Supply Chain, Regulatory Affairs, Medical, and Commercial teams.
Qualifications & Experience:
  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
  • 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.
  • Practical knowledge of TGA regulations and PIC/S GMP guidelines.
  • Experience with Medsafe (NZ) regulations highly advantageous.
Skills & Attributes:
  • Exceptional communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Excellent organisational and project management skills.
  • Proactive and pragmatic approach to quality management.

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