The OpportunityWe are looking for an experienced Senior Associate Quality Assurance (QA) to join the CSL Behring Quality team based at Broadmeadows (Australia) on a fixed term basis until 31 July 2025 (maternity leave replacement). Reporting to the Manager QA Value Stream Release, you will review batches of intermediate, semi-finished and finished product and authorise their release. You will also help review quality issues related to post-release actions including Product Technical Complaints (PTC) and Adverse Event Investigations (AE).
The RoleBased onsite at Broadmeadows and working with a diverse team, you will:
Review the relevant product portfolio batch / release documentation to ensure that intermediates and final product are suitable for further processing or release and report any issues identified;Perform detailed review of batch records for starting materials, intermediate and final products;Perform batch dispositions of plasma, intermediates, and semi-finished including completing SAP transactions and preparing documentation required;Coordinate PTC investigations and Adverse events to identify the root-cause and appropriate corrective and preventive actions;Participate in internal inspections and regulatory inspections to support compliance requirements;Perform SAP master data management for QA release;Provide training to value stream production partners;Work with other Quality teams across the network in Batch Release to improve and standardise the quality processes and standards. Your skills and experienceTo be considered for this role you have:
A Bachelor's Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience;5+ years' experience working in a similar role in pharmaceutical manufacturing or other regulated manufacturing industry;3+ years experience working with GxP and local and international regulatory requirements i.e. TGA and FDA;Experience making risk based quality decisions with relevant justifications;Experience in TrackWise or Veeva and electronic document management systems (eDMSs); How to apply:Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-231311 by 19 May 2024. #LI-Onsite
Our BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
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