Be part of a supportive and stable working environment
Working within a global team
About the company Work within a large global Biotechnology company that boasts a good company culture that is always expanding.
About the opportunity Reporting to the Sterility Assurance SME, the Sterility Assurance Associate will be responsible for the oversight and life cycle management of Sterility Assurance controls governance, validation controls and monitoring controls at the site.
Report writing, trending
Author risk assessments, protocols and reports, environmental monitoring and media fills
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 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
Skills and Experience
A Bachelor of Science is required for this role
Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic clean room facilities, their processes and equipment, including design, validation and monitoring, life cycle management and cGMP compliance
Minimum +3/+5 (Associate/Senior Associate) years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
Extensive professional experience with respect to aseptic clean rooms, processes, equipment, validation, microbial monitoring, aseptic behaviours and gowning
Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines
Experience in the manufacturing of biologics
Direct experience executing Quality Assurance functions and systems within a manufacturing and QC Microbiology/Sterility Assurance context
Experience in interacting with regulatory authorities including submissions and inspections
Knowledge of auditing practices and procedures
Own car and licence required as some driving may be required
Culture Although a large, global company, they can provide a family-like culture and prides itself in improving the lives of others.
Why this opportunity is right for you This is a Full-time 12-month contract opportunity based in Northern Melbourne. Work is Monday to Friday with the majority required on site.
How to Apply Click apply or contact Rohan Lallbeeharry – Senior Recruitment Consultant on 03 9938 7115 for a confidential discussion.
BenefitsOpportunity to work with an experienced quality team.Free onsite parkingEmployee Assistance ProgramHybrid role -60% Onsite and 40% from home.PT role -4 days.Supportive management team About the company A global pharmaceutical leader who fosters a diverse, collaborative, and inclusive...
BenefitsExpand on QA compliance experience.Free Onsite Parking.Gym onsite.5 mins walk from train/metro station.Monthly social activities.Onsite every day.Occasional interstate travel, max 3 times per year. About the company This expanding organization specializes in delivering ...