Computer Systems Validation Associate

7 days ago


Melbourne, Australia Bell People Consultants Full time

Global Pharmaceutical Organisation
- Excellent Long Term Contract Opportunity
- Hybrid Role - 3 days WFH & 2 days on site.

**About the Company**

Operating as a leading global multinational manufacturer our client is one of the world’s leading global pharmaceutical manufacturers renowned for its worldwide innovative technologies and research and development programs.

Due to new project requirements, an opportunity has arisen for an experienced Computer Systems Validation Associate with specific experience in IT Quality Management systems and experience in computerised systems validation to work on a major pharmaceutical based project.

**About the Opportunity**

Reporting to the Senior Quality Manager, key duties include the following:

- Define validation strategies for computerised systems, maintain & support IT Quality related process such as change management, defect management and IT document management.
- Review various regulatory risk assessments & protocols in relation to computer system validation practices.
- Provide QA oversight & approval of changes, deviations & investigations involving GxP computerised systems.
- Manage & support preparation for internal audits and external audits and quality systems documentation to facilitate continuous improvement
- Engage key stakeholders in cross functional teams such as quality, validation and manufacturing through quality reviews, feedback & suggestions.

**About you**
- Tertiary Qualifications in IT computer systems, engineering or a related disciplined.
- Sound understanding of IT Quality management systems & principles.
- Experience in computer systems validation & qualification.
- Strong technical & analytical skills with the ability to manage complexities.
- Good planning & organisational skills.
- Excellent communication & well developed interpersonal skills.

**Culture& Benefits**

This is a challenging & excellent opportunity for a talented individual with sound computer systems validation (CSV) experience to join this leading global pharmaceutical organisation to further develop their skills & experience within CSV & be involved in a variety of local & global projects.

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