Sterility Assurance Specialist

7 days ago


Sydney, New South Wales, Australia Evolvescientific Full time
About the Role

Evolvescientific is seeking an experienced Sterility Assurance Specialist to join our team in a permanent capacity. As a key member of our organization, you will be responsible for leading the development and implementation of a contamination control strategy (CCS) to ensure the highest level of sterility assurance in our sterile manufacturing facility.

Key Responsibilities
  • Subject Matter Expert for Sterility Assurance Function
  • Lead Investigations, Risk Assessments, and CI Initiatives Relating to Sterility CCS
  • Design and Validate Equipment Across the Whole Manufacturing Facility to Meet PIC/s Guidelines
  • Monitor and Report on Sterility Assurance Metrics and Trends and Initiate Complex Investigations into Deviations and CAPAs
  • Lead Sterility Assurance Education Programs Across the Nuclear Medicine Business
  • Oversee Transition to Revised PIC/s Code to GMP Annex 1
Requirements
  • Tertiary Qualifications in Science or Engineering Essential
  • Experience in a Sterile/GMP Pharmaceutical Manufacturing Facility
  • Experience in Contamination Control and Its Design and Implementation
  • Strong Knowledge in TGA/PIC/s and Other Relevant Regulatory Bodies
  • Excellent Interpersonal and Communication Skills
What We Offer
  • Band 6 - $107-120K + 15.4% Salary
  • Parking, Childcare, Gym, Swimming Pool, Café on Site
  • Permanent Government Role
  • Training, Development, and Mentoring Opportunities
  • Performance-Based Salary Increases
  • Work-Life Balance with Generous Leave Entitlements and Flexible Conditions


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