Specialist Qa Ts

Amgen Australia Pty Ltd

Fully remote
Quality oversight for validation
Technology transfer activities
New product introduction
Amgen Australia is seeking a Specialist QA Technical Support for New Product Introduction (NPI) to provide quality oversight in the introduction of new lines and equipment. The ideal candidate should possess at least seven years of experience in the pharmaceutical or biotechnology industry, with a strong focus on quality assurance and regulatory compliance

Job Summary

  • The Quality Assurance Technical Support Specialist NPI (New Product Introduction) is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
  • This role requires a strong focus on QA leadership in the qualification of facilities, equipment, and process validation ensuring all qualification and validation activities meet Amgen and regulatory standards.
  • In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents.

Matching Summary

Match Score: 85

Amgen Australia is seeking a Specialist QA Technical Support for New Product Introduction (NPI) to provide quality oversight in the introduction of new lines and equipment. The ideal candidate should possess at least seven years of experience in the pharmaceutical or biotechnology industry, with a strong focus on quality assurance and regulatory compliance.

Skills & Requirements

Must-have

  • Quality Oversight for validation
  • technology transfer activities
  • New Product Introduction
  • aseptic product
  • validation documentation review and approval
  • SAP BOMs, MBRs and recipes review

Nice-to-have

  • strong organizational skills
  • work independently and remotely
  • strong critical thinking
  • problem-solving abilities
  • team player
  • embrace a team-based culture

Key Requirements

  • University degree in a Science-related discipline
  • Minimum of 7 years' relevant experience
  • Experience working in aseptic operations
  • Proven experience in Quality Systems

Work Rights

Not specified

Tailored Resume

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