Highly Skilled QA Professional Wanted

2 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $124,999
Quality Assurance Professional

Sun Pharma is a leading global pharmaceutical company seeking a highly skilled Quality Assurance professional to join our dynamic team in Sydney, Australia. As a key quality point of contact, you will be responsible for ensuring that all products supplied in Australia and New Zealand meet the stringent local regulatory standards of the TGA and Medsafe, as well as Sun Pharma's global quality requirements.

Key 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 (OOS) results. Develop and implement effective Corrective and Preventive Actions (CAPAs).
  • Act as the primary quality liaison with the TGA and Medsafe regarding quality defects, GMP non-compliance, and other significant quality matters.
  • Oversee the end-to-end Product Quality Complaint (PQC) process, from intake and investigation to trend analysis and reporting, ensuring timely closure and communication with stakeholders.
  • Manage and coordinate all aspects of local product recalls, from initiation and risk assessment to execution and reporting to the TGA/Medsafe, ensuring compliance with Australian recall procedures.
Qualifications & 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).

We offer a competitive salary package, opportunity to work for a leading global pharmaceutical company, supportive and collaborative team environment, professional development and career progression opportunities, flexible working arrangements, and a focus on employee well-being.

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