The OpportunityWe are looking for an experienced Senior Associate, Frontline Quality Assurance (Deviations) to join our dynamic team in the Quality Assurance (QA) function at Seqirus, Parkville (Australia). In this full-time Fixed term position you will provide QA expertise to ensure compliance with the Quality System, cGMP and regulatory guidelines and help investigate deviations and other quality issues. You also will work with colleagues across the site to provide QA advice for the smooth operation of quality processes and provide approval for breakdowns, maintenance works and interventions that have the potential to affect product quality.
The RoleReporting to the Manager QA Frontline, you will:
Review and approve deviations and CAPAs following the requirements of global and site procedures and regulatory requirements;Perform quality impact assessments of deviations and other quality issues to ensure risks are assessed and mitigated;Perform root cause analysis, identify CAPA(s) and determine product disposition;Provide quality oversight for shopfloor activities across the business;Provide approval for maintenance works and interventions that have the potential to affect product quality;Identify and implement continuous improvements;Prepare reports for the Product Quality Review (PQR) process;Review and approve GMP documentsYour skills and experience:To be considered for this role, you have:
University degree in a relevant scientific discipline (Pharmacy, Chemistry, Microbiology, Biochemistry);5+ years' GMP experience in pharmaceutical/biotech or other regulated industry;3+ years' experience in the deviations/investigations process in the pharmaceutical industry;Experience applying current Good Manufacturing Practices (cGMP) principles;Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems;Experience in a role requiring the communication of complex information including technical writing;Experience in a role requiring analysis and accuracy;Experience completing goals within established time frames;Knowledge of TrackWise, SAP, LIMS and documentation management systems. How to apply:Please send us your resume and covering letter (in one document), addressing the key selection criteria. Applications close on 2nd October 2024.
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Our BenefitsCSL 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 usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus! Watch our 'On the Front Line' video to learn more about CSL Seqirus
