Sterility Assurance Specialist

1 week ago

Broadmeadows, Victoria, Australia Evolve Scientific Full time
About the Role:

We are seeking a highly skilled Sterility Assurance Specialist to join our dynamic team at Evolve Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of sterility assurance in our aseptic manufacturing processes.

Key Responsibilities:
  • Quality Standards Oversight: Support the development and implementation of quality standards and systems aligned with sterility assurance regulations.
  • Validation and Qualification: Conduct thorough validation and qualification of facilities, equipment, processes, personnel, and methods to ensure compliance with sterility assurance standards.
  • Expertise and Guidance: Provide expert guidance to site personnel on sterility assurance standards, culture, and continuous improvement initiatives.
  • Quality Assurance Oversight: Ensure QA oversight of quality standards and systems aligned with the sterility assurance function in the dedicated Value Stream area.
  • Collaboration and Communication: Partner closely with peers in Global and Local Quality Sterility Assurance to ensure standardized principles and systems are applied across all sites.
Requirements:
  • Education and Experience: A degree in Microbiology or a related field, with a background in aseptic manufacturing and sterility assurance.
  • Skills and Qualifications: Excellent communication and stakeholder management skills, with the ability to manage multiple priorities and deadlines.

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