Quality & Validation Specialist | Tullamarine

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Synergie Australia is seeking a Quality & Validation Specialist for a trusted client located in Tullamarine.

The important parts:

- Pay: Competitive hourly rate + Super | Duration: 12-month contract (potential for extension)
- Hours: Monday-Friday, standard business hours | 38 hrs per week
- Location: Tullamarine | Hybrid working arrangement (3 days onsite)

What you will be required to do:

You'll be a key subject matter expert supporting Quality Control method validation activities within a highly regulated laboratory environment. This role combines technical expertise, problem-solving and project leadership to ensure compliant and effective testing methodologies across the site.

- Maintaining the compliant status of the QC method validation lifecycle
- Leading troubleshooting investigations and resolving technical challenges relating to QC test methods
- Managing CAPAs and Change Controls associated with method improvements
- Providing SME oversight for method standardisation and robustness programs
- Developing and improving current and new analytical test methods
- Coordinating intra-site method transfer activities
- Supporting regulatory filings and audit activities through technical expertise
- Designing and executing validation, development and transfer studies
- Managing and coordinating AST studies and key validation projects
- Reviewing validation data and identifying trends, deviations and improvement opportunities
- Influencing QC leadership on method improvements and replacement strategies
- Staying abreast of emerging testing technologies, equipment and industry best practice

To be successful in the role you will:





- Hold a Bachelor's degree in a relevant scientific discipline
- Have robust microbiology and/or biochemistry experience
- Demonstrate experience in method validation, method development and method transfers
- Possess strong troubleshooting and technical problem-solving capabilities
- Have experience managing investigations, CAPAs and Change Controls
- Be comfortable working within a regulated laboratory or pharmaceutical environment
- Demonstrate strong project coordination and stakeholder management skills
- Have excellent written and verbal communication skills
- Experience using plate reader software will be highly regarded

What's on offer for you:

- Join a leading pharmaceutical organisation in a specialist technical role
- 12-month contract with potential for extension based on project demand
- Hybrid working arrangement with 3 days onsite in Tullamarine
- Opportunity to lead validation, method improvement and technology initiatives
- Collaborative team environment with exposure to cross-site projects
- Work with cutting-edge analytical testing technologies and processes

Synergie Australia delivers a full 360º recruitment solution, consisting of temporary and permanent recruitment services, and more. Safety is of the highest priority, and Synergie Australia prides itself on fostering a culture that champions guidance and care in the workforce. Beyond recruitment, Synergie Australia is motivated to improve everyday standards within the working landscape so people can thrive today, and in the future. This approach delivers real change to communities by improving workplaces, local economies, inequalities, and changes to the climate. If you aspire for better, let's work together.

If you're ready, click apply now or contact our branch on 03 9252 2222.

Synergie Australia connects people with safe, rewarding work across Australia. From temporary roles to permanent opportunities, we support you at every stage of your career. Learn more and view current opportunities at www.synergieaustralia.com.au.

📌 Senior Validation Specialist (North Melbourne)
🏢 Synergie Australia
📍 North Melbourne