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