Senior Sterility Assurance Expert
7 days ago
Evolve Scientific is seeking an experienced Sterility Assurance Specialist to lead our clients’ sterile manufacturing facility in the design and implementation of a new contamination control strategy. The ideal candidate will have a proven track record in sterile contamination control validation and experience in a senior level sterility validation role.
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
Please send a cover letter and detailed resume in WORD format to apply.
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Sterility Assurance Specialist
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Lucas Heights, Australia Evolve Scientific Full timeAbout the RoleEvolve 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...
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