Sterility Assurance Specialist
- Join a global pharmaceutical company as a Sterility Assurance Specialist.
- Conduct environmental and personnel monitoring, in-process testing, and microbiological method development.
- Provide QA oversight and collaborate with cross-functional teams to ensure adherence to Sterility Assurance standards.
About the company/role:
- Global pharmaceutical company
- Based in Northern suburbs of Melbourne
- Seeking a Sterility Assurance Specialist to join this dynamic team
- 12-month casual contract
- Monday-Friday, normal business hours
- Hybrid role (3 days onsite)
Duties include, but not limited to:
- Environmental and Personnel monitoring, In-process testing, finished product testing, microbiological method development
- Validation and qualification of the facility, utility and equipment, process, personnel and method at the site
- Cleaning and disinfection, hygiene, operator training, gowning and behaviour, facility design and process design at the site
- Provide expertise to the site related to Sterility Assurance standards, culture and continuous improvement
- Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and standards related to Sterility assurance governance and drive improvements
- Provide QA oversight of quality standards and systems aligned with the Sterility Assurance function in the above areas for the site
- Ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organisation
- Trending & data management, stakeholder management
Skills/experience required:
- Tertiary education in Microbiology, Pharmaceutical Science, Biological Sciences or related discipline
- Proven experience in a similar role within aseptic manufacturing
- Must have a strong background in microbiology or aseptic manufacturing
- Experience within pharmaceutical manufacturing is ideal, but open to hospital/medical industry
- Excellent written and oral communication skills and strong time management
- Experience with Excel and trend analysis
- Strong problem solving skills
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letterAND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Linda Mork on *********
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