Computer Systems Validation Specialist

4 months ago


Brisbane, Australia HAYS Full time

Exciting opportunity to join a growing company based in Brisbane

**Your new company**

This is a growing organisation based in Brisbane creating innovative technologies to support patients across the world.

**Your new role**

This is a combined technical and training/mentoring role within the Quality department. The role will develop protocols and write reports for validation activities associated with computerised systems, including those controlling facilities, utilities, equipment and QMS tasks. The role will also involve either executing the validation activities, or training and supporting system owners/SMEs/vendors to perform them.

**What you'll need to succeed**
- PIC/S Annex 11 Computerised Systems and Annex 15 Qualification and Validation
- 21CFR Part 11 Electronic Records; Electronic Signatures
- GAMP5
- ISO13485
- 21CFR Parts 210 and 211
- PIC/S Code of GMP
- Quality Management Systems (QMS)

**What you'll get in return**

This company offers a competitive salary and bonus as well as an opportunity to opt in for a 9-day fortnight. You will be working in a brand-new facility working with top-of-the-range equipment.

**What you need to do now**

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

2845741


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