Aseptic Processing Specialist

5 days ago

Melbourne, Victoria, Australia beBeeSterility Full time $45,000 - $81,000
About the Opportunity

This role offers a chance to work in a global team and contribute to the oversight and life cycle management of sterility assurance controls governance, validation controls, and monitoring controls at our sites.

Key Responsibilities
  • Reporting and Trending: Author risk assessments, protocols, and reports.
  • Environmental Monitoring: In-process testing, finished product testing, and microbiological method development.
  • Validation and Qualification: Validation and qualification of the facility, utility, and equipment, process, personnel, and method.
  • QA Oversight: Provide QA oversight of quality standards and systems aligned with the Sterility Assurance function.
Requirements
  • Bachelor of Science degree required.
  • Strong technical knowledge in sterility assurance of aseptic clean room facilities, processes, and equipment.
  • Minimum 3-5 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing.
  • Experience in quality assurance and regulatory compliance with GxP, FDA, EU, and other regulatory agency guidelines.
Culture

A large company that provides a family-like culture and prides itself in improving the lives of others.

What We Offer
  • A competitive compensation package.
  • Ongoing training and professional development opportunities.

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