Validation Associate
5 months ago
The Opportunity
Derived from the expression 'securing health for all of us', CSL Seqirus is a global leader in influenza protection. In Asia Pacific we also manufacture and distribute a range of uniquely Australian products market a range of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.
We are looking for a Validation Associate to join our Quality Assurance (QA) Validation team in Parkville on a full-time fixed term basis until 30 June 2026 . Reporting to the Validation Manager, you will provide validation support for process, cleaning and equipment and any projects. You will also support revalidation activities across the Seqirus business.
The Role
Based on-site at Parkville (Australia) but with some time required at Tullamarine, you will:
Perform the validation activities associated with changes to existing plant, equipment and processes and the project validation activities as determined by the Validation Project Facilitation department to deliver successful validation outcomes for the Seqirus Australia business
Perform validation activities following the Quality Management System, Site Validation Master Plan, Business Improvement and Validation procedures to meet the requirements of all codes, regulations and policies
Prepare, implement and maintain departmental documentation for validation activities and regulatory submissions (e.g., Validation protocols and reports, Executive Summaries and Validation Master Files)
Build and maintain collaborative relationships with important partners
Participate in internal (e.g., Quality Compliance, Safety and departmental) and external (e.g. TGA, FDA) audits
Participate in problem solving and identify opportunities for improvement to optimise validation activities
Ensure all training certification requirements are up-to-date.
Follow the documented procedures to maintain a safe work environment in compliance with Seqirus policies, procedures and statutory obligations
Assist with EHS Risk Assessments and the implementation of safety improvement plans
All employees shall ensure their own and others health, safety and security at work.
Your skills and experience
To be considered for this role you have:
A bachelor’s degree in an Engineering or Science related field;
3+ years’ experience in the Pharmaceutical Industry in a validation, quality assurance or engineering related role, applying validation protocols to systems, processes, cleaning and equipment.
Knowledge of the manufacturing of sterile injectables.
Knowledge of GMP, QMS and Risk Management.
Experience in a role requiring cross site collaboration and multi-tasking.
Excellent communication skills including experience in technical writing.
Experience with machinery and equipment.
How to apply
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-234141 by 4 July 2024.
#LI-ONSITE
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
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