GxP System Analyst

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Full Time
Sydney
Posted 1 month ago

GxP System Analyst

Reports to: Principal GxP System Specialist

Why you’re here

Ideally Sydney-based, you will work with GLC Laboratory, Clinical Operations, and Project Management team members to understand end-to-end process workflows and the associated relevant software applications.  You will drive and contribute to process reengineering initiatives, elicit and document requirements and specifications, and act as the facilitator between the Subject Matter Experts (SMEs), IT Team, and GLC GxP end users. 

Utilising your experience in either Engineering, IT, R&D or Quality in this you will ensure compliance and perform quality management activities related to GxP qualification/validation and change management observing GxP regulatory requirements and industry best practices.

What you’ll deliver

  • A defined test strategy, creation of test plans and test scripts that ensure implementation is complete and correct.
  • End-to-end integration work.
  • Subject Matter Expertise in meetings with vendors, service staff, project team members.
  • Optimal and efficient systems.
  • Effective governance of site implementations.
  • Quality monitoring and outstanding service performance.

How we’ll measure it

  • End-User Experience – where possible ensure that all end users globally have seamless GxP Systems support and service.
  • Performance in incident ticket analysis and through a total number of resolved incidents.
  • Collaboration and team working and clear communication among different teams globally.
  • Meet demanding deadlines and ability to work simultaneously on multiple priorities in a fast-paced entrepreneurial environment.

What you’re responsible for

  • Analyse, configure, troubleshoot, administration, and maintain GxP systems to ensure optimal performance.
  • Review, analyse and capture business system and user need requirements, define objectives, and formulate systems processes.
  • Identify opportunities to harmonise and simplify system processes.
  • Identify and articulate the impact of the proposed modification with a comparison of current and future state processes.
  • Conduct testing of IT solutions within project timelines.
  • Support system changes whilst maintaining GxP qualification/validation and regulatory compliance
  • Manage deviations, collect information, investigate, and report on non-conformance issues.
  • Provide technical skills to prepare and write SOPs, Work Instructions, Validation, and Decommissioning documentation following GAMP5 Framework and best practices.
  • Defined test strategy, creation of test plans and test scripts to ensure implementation is completed correctly.
  • Assist with the end-to-end integration work at each identified service using your experience and knowledge of the Information Systems used by the service.
  • Attend and provide Subject Matter Expertise in meetings with vendors, service staff, and project team members to ensure all integration and testing matters are considered and managed according to best practice.
  • Assist in the integration testing, smoke testing and User Acceptance testing at each site and provide go-live support to ensure optimal use and efficiency of the system.
  • Document the system integration processes and workflows to ensure effective governance of each site’s implementation approach.
  • Support the clinical data collection program of work to contribute toward quality monitoring and understanding service performance.

Qualifications

  • Degree in information systems/Technology, Computing or a combination of education, training, and relevant industry experience.

Work experience

  • A minimum of 2 years of working experience in supporting GxP systems in a Pharmaceutical, CRO, or laboratory/pathology environment.
  • Familiarity with GxP system validations, 21 CFR Part 11 regulations for electronic systems and compliance in clinical trials.
  • Knowledge of clinical/health systems and Lab Information Systems is advantageous.

Technical knowledge & skills or other requirements

  • Bachelor’s Degree in Business Administration, Engineering, Computer Science or Management Information Systems, Life Sciences, or any other equivalent degree or experience.
  • Working knowledge with Relational Database Management Systems (RDBMS).
  • Experience with GAMP®5 Framework.
  • Understanding of laboratory equipment, systems, and software.
  • Ability to prioritise tasks, multitask with organisation and manage time effectively.
  • Strong customer focus and ability to manage (internal or external) client expectations.
  • Ability to work independently with limited oversight, in a complex global environment.
  • Experience in PowerShell scripts and SQL will be highly regarded.

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