20 Sep
|
Evolve Scientific
|
Melbourne
20 Sep
Evolve Scientific
Melbourne
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 solid 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-*****-Ljbffr
📌 Sterility Assurance Specialist (Melbourne)
🏢 Evolve Scientific
📍 Melbourne