Validation Specialist

1 week ago

Parkville, Australia Seqirus A CSL Company Full time

The Opportunity

Located in Parkville (Australia) and part of the Analytical Sciences and Technology (AS&T) Department a 12 month fixed term contract opportunity has become available for a Validation Specialist to participate in the validation and implementation of scientific methods and technologies into the Quality Control laboratories.

The Role

Specifically, the Validation Specialist will:

- Demonstrate supervision and support for timely implementation of projects and ensuring training requirements are met.
- Participate in routine internal audits, ensuring all audit items are closed out as per agreed timeline.
- Participate and perform in document write up and review for Regulatory submissions.
- Collaborate with QC, Production, QA, Document Control, and all R&D groups to implement selected technologies into the QC laboratories.
- Collaborate with external colleagues and companies to maintain knowledge of current assay developments and current scientific technology.
- Participate in Assay Development Teams including attending team meetings, creating required documentation, and conducting assessment testing.
- Contribute to Assay Development Teams to ensure milestones are met for development and transfer with efficient use of labour and material resources.
- Create required documentation as outlined in relevant procedure for testing and standard operating procedures for implementing new methods and technologies.
- Conduct analyst training within AS&T and QC Laboratories for transferred technologies.
- Maintain associated databases of relevant information to AS&T and support project monitoring systems.

Your skills and experience
- A Bachelor of Science or equivalent
- Previous laboratory testing experience
- Demonstrated experience in biochemistry and/or chemistry techniques will be highly regarded
- Previous experience in a quality environment
- Good technical and mechanical aptitude
- Excellent Microsoft Office Skills

In addition, you have:

- Previous experience working in the Pharmaceutical industry
- Sound understanding of the process for the development and validation of analytical test methods.
- Understanding of the ICH/EMEA guidelines and Pharmaceutical Regulatory Requirements
- Previous experience in project management

How to apply

Our Benefits

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.

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 us

As 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

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