About the company
Our client is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. They are seeking a Validation Analyst to assist their already well-established Engineering Team.

Key responsibilities

The appointee will play an essential role in the I&T organization by providing crucial computer validation services and audit and inspection support services. This role requires the development of close collaboration and productive relationships with the Digital Quality function, the many I&T support towers, and their third-party support partner.

• Preparing validation documents
• Working with key stakeholders
• Chasing completion of tasks
• Change controls
• Quality admin tasks
• Review of documentation, creation of documentation related to applications
• Responsible to develop typical validation deliverables including: plans, reports, and specifications. Generally, test cases will be written by others.
• Assists the CSA lead in driving project validation strategy

About you

Education
Bachelor’s degree with study in scientific, engineering, or computer systems focus
is preferred. Work experience can replace this requirement.

Experience

• 3+ years of experience in computer systems validation
• Life sciences industry experience preferred but other heavily regulated industry experience is also recognised.
• Experience working across a range of countries and cultures is preferred
• Experience working with an Application Lifecycle Management system (e.g. HP ALM, Codebeamer, Val Genesis) is ideal.

Competencies

• Working knowledge of GAMP 5
• Knowledge of other lifecycle models is preferred
• Excellent written communication skills
• Excellent understanding of change management principles, techniques & tools.
• Good listening and verbal communications skills.
• Analytical mindset and critical thinking.

How to Apply
Click apply or contact Maddy Rhodes–Laird, Senior Recruitment Consultant on 03 9938 7101 for a confidential discussion.