Senior Associate Pharmaceutical Quality Assurance

We're looking a Senior AssociateQuality 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.

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

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.

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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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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus