Sterility Assurance Specialist
1 month ago
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
- 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
- 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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