Job Description
My client, a leading Global pharmaceutical company, is currently is seeking a Computer System Validation Specialist to join on a three month contract sitting in the IT Compliance Department.
The successful candidate will be responsible for:
- Maintaining manufacturing and process equipment computer systems
- Computer validation of computerized laboratory instrument systems
- Establishing user and functional requirements in the context of FDA and TGA-regulations
- Preparing documentation in accordance with company and compliance objectives
- Completing functional risk assessments with relevant parties
- Writing tests against the identified functions and functional risks, then executing the tests.
Skills & Experience:
The successful applicant will be able to demonstrate:
- A tertiary qualification in Engineering OR Computer Systems
- Understanding of the TGA (PIC/S) and FDA regulations relating to computerized systems and GMP.
- Ability to identify user requirements and risks associated with them in the context of patient safety, product quality and data integrity.
- Expertise in the use of MS Word.
- Prior experience in the pharmaceutical industry with computer system validation is advantageous
- Strong attention to detail
- Effective time management skills
APPLY WITHIN or contact Saba Khazeie on (03) 9020 1999 or saba@siriustechnology.com.au
