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Quality Assurance Specialist

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Sydney, New South Wales, Australia beBeeQuality Full time $100,000 - $140,000

As a Quality Assurance Specialist, you will play a vital role in ensuring the quality of medicinal products. Your primary responsibility will be to conduct batch reviews and releases in accordance with TGA requirements and local procedures.

You will also contribute to the investigation and resolution of GMP non-compliance issues, deviations, and out-of-specifications results. This will involve developing and implementing effective Corrective and Preventive Actions (CAPAs).

Key Responsibilities:
  • Authorise the final disposition of imported therapeutic goods
  • Investigate and resolve GMP non-compliance issues
  • Liaise with regulatory authorities regarding quality defects and non-compliance
  • Manage product quality complaints and recalls
  • Ensure compliance with Australian recall procedures
  • Provide quality oversight for third-party logistics providers
  • Support Regulatory Affairs team with TGA GMP Clearance applications
Requirements:
  • Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field
  • Minimum 2-3 years experience in Quality Assurance role within pharmaceutical industry in Australia
  • Demonstrated experience as an Authorised Person for product release under PIC/S Guide to GMP
  • In-depth knowledge of TGA regulations and PIC/S GMP guidelines

This is an excellent opportunity to advance your career in Quality Assurance and make a significant contribution to the success of our company.

About Us:

We are a leading global pharmaceutical company with a strong presence in Australia and New Zealand.

What We Offer:

Opportunities for professional growth and development

A collaborative and dynamic work environment

A competitive salary and benefits package