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Computer Systems Validation (CSV) Specialist

Job Title: Computer Systems Validation (CSV) Specialist
Contract Type: Contract
Location: Australia, Australia
Industry:
Salary: Negotiable
Reference: 104215_1554099378
Contact Name: Saba Khazeie
Contact Email: saba@siriustechnology.com.au
Job Published: April 01, 2019 17:16

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

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