Sterility Assurance Assoicate, 1 Year Contract

2 weeks ago

Melbourne, Victoria, Australia Peritus Recruitment Full time

General Detail

  • Role is for 1 year to start ASAP (but will wait for the right person)
  • Reason for vacancy: Ongoing project, need to increase the numbers to support delivery of project
  • Team size: 10
  • Flexibility?: some flex to do some hours from home when drafting up documentation but majority onsite
  • Hours: Standard Mon to Fri
  • Reports to: Sterility Assurance Project Lead

Role Duties and Responsibilities
Reporting into the Sterility Assurance SME, the Associate / Senior Associate, Sterility Assurance 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, Inprocess 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 his or her 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 company 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

Essential Experience and Background

  • A minimum of a Bachelor Degree in Microbiology/Biology life sciences or equivalent qualification or experience
  • 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 function and system within a manufacturing and QC Microbiology/Sterility Assurance context
  • Validation and qualification experience from quality assurance, environmental monitoring, media fills perspective
  • Aseptic behaviours and techniques
  • Provide feedback and have good negotiation skills

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