Project Coordinator Quality Control
Job Type: Full time
Come and be part of the exciting project constructing our advanced Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia). Expected to be completed in 2026, this facility will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere and will also produce unique products important to Australia's public health needs such as snake and spider antivenoms.
As the Project Coordinator for the Broadmeadows (BMW) Quality Control (QC) site you will you will provide subject matter expertise to incorporate the project’s future QC operational requirements into the existing QC work structure. You will work with the project team and BMW QC Managers to support all aspects of the design, integration, qualification, and validation of the QC laboratories and testing processes. You will help in all aspects of identification, set up and regulatory readiness for the QC testing of Seqirus products at Broadmeadows.
In this full-time on site role you will report to the Director QC BMW and based at the Broadmeadows site and you will:
- Provide technical direction in the development and commissioning of the QC laboratories at Broadmeadows for testing of Seqirus products;
- Implement new equipment, methods and testing procedures and update all standard operating procedures to accommodate Seqirus products;
- Maintain project timelines and budgets for all equipment and resolve quality issues and performance measures for management review;
- Initiate and maintain all change control activities to ensure project delivery;
- Work with Seqirus QC Banksia, to oversee method transfer activities to the Broadmeadows site;
- Work with QC Raw Material & Sample Logistics Lead and the project QC Systems to ensure testing of Raw Materials at BMW site;
- Manage a small team to ensure project is delivered on time.
Your skills and experience
To be considered for this role you have:
- A Bachelor’s degree in related scientific field or equivalent;
- 5+ years in a GMP regulated environment and / or Quality Control within the pharmaceutical industry;
- 3+ years’ experience in laboratory operations;
- Understanding of Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems including a working knowledge of GMP requirements, and working with Regulatory Agencies such as TGA and FDA;
- Experience making and justifying quality decisions based on risk management principles;
- Experience leading, motivating and developing team members to achieve outcomes;
- Experience in a role requiring collaboration and persuasion to influence outcomes.
How to apply
Please send us your resume and covering letter which addresses the criteria above (in one document) and includes reference number R-199273. Applications close 21st March 2023.
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