Data Validation and Support Specialist

360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.   Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.
To provide IT and application support for a range of scientific applications, with adherence to industry best practice and relevant regulatory guidelines. 

Key Responsibilities Areas

• The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.

Information Systems

• Be actively involved in performing Computer Systems Validation activities, particularly with spreadsheets validation as according to the spreadsheet validation SOP.
• Create, update and/or review validation documents including but not limited to spreadsheet/user requirements, test plans, IQ/OQ/PQ tests, UAT and reports
• Writing and reviewing validation documentation that meet regulations and requirements, including change management activities
• Facilitate and conduct functional risk assessments
• Liaise with stakeholders (vendors, subject matter experts, testers) in the planning and execution of CSV projects
  • Includes prospective, concurrent and retrospective validation
  • Includes spreadsheet validation
  • Where required, prepare spreadsheet templates and validate their use according to SOP.
  • Review spreadsheet templates if prepared by others and assist in validating their use
  • Be involved in maintaining validation of computerised systems and spreadsheets
  • Assist in maintaining Computer Systems Validation SOPs and Templates
  • Must be highly proficient with the use of Excel, particularly with formulas, functions and protecting spreadsheets
  • Provide application support for a wide range of scientific applications. This includes covering the entire lifecycle of application systems, from strategy through to support and retirement
  • Be involved in investigating, analysing hardware and software problems, and ensuring relevant validation documentation are updated
  • Contribute towards scientific system upgrades, installation, integration, customisation and configuration, and ensure validation documents are updated accordingly