AddressThe 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 term role until 31st March 2025.
Based at Tullamarine, as the LIMS & Environmental MonitoringData 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. You will also complete specification documents, to facilitate critical testing of raw material, utilities, Environmental Monitoring (EM), and manufactured products.
The Role
Reporting to the QC GLIMS / EM SME and Raw Material & Sample Logistics Lead 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
- Complete raw material / product and utility / EM specifications documents to support creation of master data and testing.
Your skills and experience
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- 226174 by March 14, 2024.
Our Benefits
CSL 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 CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
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