QC - PNS Team Leader
The Opportunity:
Derived from the expression 'securing health for all of us', Seqirus has public health protection at its core. As a global leader in influenza protection, Seqirus has one of the broadest influenza vaccine portfolios in the world. In the Asia Pacific region, we also market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand. We also manufacture and distribute a range of uniquely Australian products under contract with the Australian Government, Products of National Significance (PNS) which includes anti-venoms and Q-Fever vaccine.
We are looking for a QC, Team Leader PNS on a full time permanent role to join our Quality Control (QC) team based in our Woodend facility. You will lead a team responsible for testing of Antivenom identity and potency, acceptance testing/receipt of incoming venoms, environmental monitoring incubation of Woodend samples. You will provide technical leadership in the development and commissioning of Quality Control (QC) Equipment and testing.
During the Banksia Project development of the Seqirus Woodend facilities, you will assist method transfer activities to the Woodend site. During this time, working from a range of CSL Seqirus sites including Parkville and Tullamarine will be required. The role location will transition to Woodend as the primary working location as construction is completed.
The Role:
Reporting to the PNS QC Lead - Woodend, you will:
- Lead and maintain a team within Quality Control (QC) to produce testing assay/validation service to an agreed plan.
- Driving process improvement and ensuring continuing compliance with code of Good Manufacturing Practice (cGMP) legal and regulatory requirements.
- Manage daily activities in the development and commissioning of QC Equipment and Assay transfer activities at Woodend.
- Evaluate performance of analytical instruments and equipment and ensuring they are qualified and calibrated following cGMP.
- Develop and implement new methods and testing procedures and maintaining standard operating procedures.
- Coordinate the preparation, review, and approval of relevant QC documentation and conduct training of QC staff on approved procedures.
- Complete investigations and ensure that appropriate action is taken when Out-of-Specification (OOS), invalid assays or unusual data is observed.
- Coordinate the conduct of stability trials including the preparation and approval of testing schedules, protocols, and reports.
- Support the preparation and sign off for Certificates of Analysis (CoA).
- Help prepare Animal Ethics and Department of Energy, Environment and Climate Action (DEECA) permit applications to enable QC method transfers and facility approvals.
Skills & Experience:
- A tertiary qualification in Biological Sciences or equivalent;
- Minimum 5 years' experience in a pharmaceutical GMP/GLP environment managing a quality team to meet business timelines;
- 3+ years' experience with biological and in-vitro analysis and instrumentation.
- Experience in a role requiring interaction and compliance with regulatory agencies.
How to apply: Please send us your resume and covering letter (in one document), which addresses the criteria above. Applications close by 16 September 2024.
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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.
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.
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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