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Senior Associate Pharmaceutical Quality Assurance
4 months ago
The Opportunity
We're looking a Senior Associate Quality Assurance (Frontline) to join our team at CSL Seqirus, Parkville (Australia) on a maternity leave contract basis until 30 May 2025 . In this on-site full-time 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 compliant operation of quality processes and provide approval for breakdowns, maintenance works and interventions that have the potential to affect product quality.
The Role
Reporting to the Manager QA Frontline, you will:
When applicable, support management of associates reporting to the role including development training and gerneral management
Liaise closely with key departments to ensure smooth effective quality processes and provide QA advice
Perform SQuIPP (quality impact) assessments of deviations and other quality issues to ensure risks are assessed and reduced
Manage the investigation process to close Product Deviations, Technical Complaints and other quality issues
Perform root cause analysis, identify CAPA(s) and determine product disposition
Implement Frontline quality initiatives with on the floor representation in key operations areas
Provide oversight and approval for issues which may affect product quality and oversee corrections to data in quality systems
Participate in Change Panel Process and review and approve change controls, deviations and CAPAs following the requirements of global and site procedures and regulatory requirements
Provide Frontline Quality Support to the manufacturing, QC and warehouse teams
Oversee corrections to data in Quality Applications and help write and maintain system documentation
Collate data for Quality Governance Metrics
Help prepare reports for the Product Quality Review (PQR) process
Facilitate risk assessments regarding Change Control, Deviation and Recall events
Your skills and experience
To be considered for this role, you have:
University degree in a science related field (Pharmacy, Chemistry, Microbiology, or Biochemistry)
Two (2) plus years' experience in a quality role in a regulated industry eg pharmaceutical manufacturing or R&D
Experience operating Quality Management Systems/Pharmaceutical Quality System (PQS) or equivalent
At least 1 years' experience working with sterile injectable pharmaceutical products
Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems
Proficient working knowledge of GMP
Experience in a role requiring the communication of complex information including technical writing
Knowledge of TrackWise, SAP, LIMS and documentation management systems
Please note you will need to adapt your work schedule to meet operational requirements, this may include overtime on evenings and weekends.
How to apply
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-230713 by 8 June, 2024 .
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Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
