Sterility Quality Assurance Associate
|Job Title:||Sterility Quality Assurance Associate|
|Contact Name:||Chris McCutcheon|
|Job Published:||May 30, 2022|
Location: Based in the Inner Northern Suburbs
Duration: 12 Months contract (possible extension)
This is an excellent opportunity for an experienced Sterility Quality Assurance Associate to join a leading manufacturing business, working on a highly interesting project. The position will be based in the Inner Northern Suburbs of Melbourne and is on a full-time contract basis.
Role and Responsibilities
The successful individual will be responsible for the oversight and life cycle management of Sterility Assurance controls governance, validation controls and monitoring controls at the site.
- 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 company 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
- Partner closely with peers in Global and Local Quality Sterility Assurance from the other manufacturing sites and ensure that the same principles and systems are applied across all manufacturing sites and that in all areas the appearance and reporting of the documentation in the stated areas is standardized.
- The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.
- Previous experience working in Projects
- Experience in aspects related to sterility assurance, Media fill concept, environmental monitoring, Aseptic filling, Contamination control
- Knowledge of Aseptic behaviours and techniques
- Experience in forming risk assessments in these areas
- Ability to Influence key stakeholders (eg project managers, production, quality)
- Min 5 yrs min in the pharmaceutical industry in aseptic manufacturing, microbiology and sterility assurance
- Exp using Microsoft Word, Excel, PowerPoint
- Work with a world class business on high profile projects.
- Work within a highly skilled team.
- Excellent remuneration.
Design & Build specializes in recruitment for the Construction, Manufacturing, Engineering & Property industries on a national basis. Design & Build prides itself on only hiring recruitment specialists, finding the right people for the right jobs and doing the right thing by both job seekers and employers alike.
For any questions relating to this role please contact Chris on 0412 747 198 / email@example.com or click apply. Your application will be treated as strictly confidential.
Thanks for your consideration.