Sterility Assurance Specialist

1 month ago


Lucas Heights, Australia Evolve Scientific Full time
About the Role

Evolve Scientific is seeking an experienced Sterility Assurance Specialist to lead the implementation of a new contamination control strategy (CCS) at our client's sterile manufacturing facility. The successful candidate will have a proven track record in sterile contamination control validation and will drive projects to design and implement a CCS alongside senior management and executive level stakeholders.

The role will oversee the transition to the revised PIC/s Code to GMP, Annex 1, through the implementation of an end-to-end contamination control strategy for the manufacture of sterile medical products.

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 the 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 - $107-124K + 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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