Computer Systems Validation Consultant

1 week ago


Melbourne, Victoria, Australia Attribute Consulting Full time
Leading Melbourne based medical/pharma company with a global presence

  • Work with a diverse group of Scientists, Project Managers and QA professionals
  • Long term contract where you can create your own footprint within the company.

The Company:


Melbourne based consulting company that delivers a multitude of solutions across best-practice advice, training, software solutions and contract labour resources to pharmaceutical, medical device and life science industry.


The Role:

  • Be actively involved in performing Computer Systems Validation activities as according to the Master Validation Plan, OECD Principles of GLP, ICH GCP, FDA 21 CFR Part 11 and other regulatory requirements.
  • Create, update and/or review validation documents (eg user requirements, test plans, IQ/OQ/PQ tests, UAT, reports, spreadsheet validation)
  • Facilitate and conduct functional risk assessments
  • Writing and reviewing validation documentation that meet regulations and requirements, including change management activities
  • Organise, participate and oversee testing as required
  • Ensure the validation of computerised systems and spreadsheets are supported and managed through the lifecycle.

Skills and Experiences:

  • Experience in validation, quality management and documentation for multiple systems including LIMS within regulated environments.
  • Excellent knowledge of IT hardware and software, including Windows Server and Desktop OS.
  • Good understanding of regulations and guidance applicable to computerised systems.
  • Excellent organisational, timemanagement and communication skills
  • Strong analytical and problemsolving capabilities with the ability to perform root cause analysis.
  • An understanding that teamwork is the path to achieving outstanding results in a fastpaced commercial work environment.


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