Job Description
The Opportunity
We are looking for a Data Administrator to join the Quality Control (QC) team on our exciting Banksia Project constructing an advanced Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia).
This is a full-time fixed termrole based at Tullamarine until 31 December 2024. As the LIMS & Environmental Monitoring Data Administrator you will ensure that the Laboratory Information Management System (LIMS), which guarantees that Products of National Significance (PNS) and Flu-Cell Culture (FCC) products, materials and processes, will continue to function. You will create master data and implement LIMS solutions to ensure the business can operate efficiently, compliantly, and uninterrupted after LIMS is rolled out to the Seqirus (Tullamarine/ Woodend) and CSL Behring (Broadmeadows) sites.
The Role
Reporting to the QC GLIMS and EM SME for Banksia, you will:
Collaborate with the Banksia QC Systems Lead, Banksia GLIMS Project Manager and QC GLIMS SME, to deliver processes and transactions relating to LIMS for Project Banksia
Conduct LIMS system testing, handover of documentation and training of the relevant business users in use of LIMS system
Implement master data updates via the change control process and associated systems
Assist and contribute to the Change Management team with the preparation and delivery of the LIMS System activities for Project Banksia and other affected stakeholders
Implement approved solutions to any feedback from the business affected by the roll-out of Quality System processes
Develop and implement new methods and procedures, as required, and maintain standard operating procedures
Ensure that all aspects of the QC LIMS project comply with the requirements of the Quality Manual and meets all relevant cGMP regulatory requirements.
To be considered for this role you have:
Bachelor’s degree in Quality, Business or IT discipline
5+ years’ experience in Quality and/or a GMP regulated environment within the pharmaceutical industry
Experience with Labware software and laboratory system operations
Experience working in a Programme environment, in a multi-system operating landscape, which may include SAP, GLIMS, TrackWise, Document Management Systems, Learning Management Systems and SharePoint
Knowledge of current Good Manufacturing Practices (cGMP) principles
Knowledge of FDA, TGA and EMA requirements
Experience in a role requiring the completion of multiple, competing, tasks within specified timelines
How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-199538 by April 19, 2023.
About Us
Our Benefits
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
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