Computer Systems Validation Consultant
1 month ago
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, time-management and communication skills
- Strong analytical and problem-solving capabilities with the ability to perform root cause analysis.
- An understanding that teamwork is the path to achieving outstanding results in a fast-paced commercial work environment.
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