Sterility Assurance Specialist
evolve scientific • Melbourne, AU
1 day ago
Job description
2mo ago , from Evolve Scientific Recruitment
- Seekinga Sterility Assurance Specialist to join this dynamic team
- 12-month casual contract
- Monday-Friday, normal business hours
- Hybrid role (3 days onsite)
About the company/role:
- Global pharmaceutical company
- Based in Northern suburbs of Melbourne
- Seekinga 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 andstandards 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 oralcommunication skills and strong time management
- Experience with Excel and trend analysis
- Strong problem solving skills
#J-18808-Ljbffr