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Quality Assurance Associate Computer Systems Validation

Ego Pharmaceuticals -
Braeside VIC

Apply Now

Job Details

Qualifications

SAP
Manufacturing

Full Job Description

QA Associate – Computer System Validation

Ensuring Compliance and Integrity in Automated Systems

Are you a validation specialist with a strong background in compliance for computerised and automated systems? Join Ego Pharmaceuticals, where we blend science with quality to create market-leading products. This is your opportunity to drive innovation, oversee critical system validations, and ensure our site-wide software and automation infrastructure remain compliant and production-ready.

The Role & Your Impact

As a QA Associate – Computer System Validation, your focus is to participate in and support the site-wide CSV strategy. You will ensure that GxP computerised and automation systems are validated in accordance with GAMP5 principles and the TGA requirements.

Your work covers the full validation lifecycle for both existing systems and new projects. You will lead validation planning, manage change controls, execute audit trail and periodic reviews, and assess system deviations. Collaborating closely with Engineering, Automation, IT, Production, and external vendors, you will maintain the validated state of our systems while supporting broader facility, utility, enterprise and equipment qualifications.

Key Responsibilities:

Validation & Assessments: Conduct computerised system criticality assessments, execute revalidations, and perform routine audit trail reviews.
Project & Change Management: Lead validation planning for new and modified systems, reviewing change controls, deviations, and related CAPAs.
Documentation & Governance: Prepare, review, and update validation protocols, deliverables, and Standard Operating Procedures (SOPs) for internal and third-party systems.
Audit Readiness: Participate in Ego’s internal audits and external regulatory inspections, serving as a subject matter expert for CSV compliance.

What You Will Bring

To be successful in this role, you will need a collaborative spirit, a keen eye for technical detail, and a commitment to continuous improvement.

Essential Requirements:

Technical Experience: Practical experience in computerised systems validation (CSV) within a regulated manufacturing environment using CSA approach
Compliance Knowledge: Sound understanding of GAMP5 guidelines and regulatory standards such as TGA, ( PICs Annex 11).
Quality Documentation: Proven ability to draft, execute, and review validation protocols, test scripts, and technical specifications.
Safety Leadership: A strong commitment to health and safety, ensuring no job is too urgent that it cannot be done safely.
Cross-Functional Communication: Liaising with diverse teams including Engineering, Automation, ICT, and external consultants.

Desirable Requirements:

Application Exposure: Experience or familiarity with PLC, SCADA, QMS, SAP and other enterprise and production applications.
Problem Solving: Troubleshooting system events and contributing to long-term continuous improvement projects.

Why Join Ego?

Benefits: Enjoy cake day every Wednesday for morning tea and access to order free Ego products.
Culture: We live by our values: Quality, People, Ethics, Innovation, Service, and Ego Spirit.
Environment: Work in a professional, safety-conscious environment where your contribution to continuous improvement and high quality standards is valued.

#LI-AE1

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If this sounds like just the right opportunity for you, click on apply now and join us on our journey for healthy skin!

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QA Associate – Computer System Validation

Ensuring Compliance and Integrity in Automated Systems

The Role & Your Impact

Key Responsibilities:

What You Will Bring

Why Join Ego?

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