Current Openings

Quality Computer Systems Technician

London

DEPARTMENT: QUALITY ASSURANCE

LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – QUALITY COMPUTER SYSTEMS SPECIALIST

Purpose of Job

Support the implementation, development and management of compliance related electronic systems in accordance with EU, GAMP and FDA GxP requirements (specifically GCP, GLP and GMP).

Perform general administration and maintenance activities required to support implemented systems.

Support Computer System Validation activities for GxP systems.

Major Activities

  • Support computer systems projects led by the Quality Computer Systems Specialist, including but not limited to:
    • Defining system requirements
    • Executing test scripts
    • Summarising validation activities
    • Defining supporting procedures
    • Liaising with business functions.
  • Develop and deliver robust training programmes for system users
  • Maintain user access for each system, including setting up new users and deactivating leavers
  • Provide technical support to the business when using implemented systems
  • Maintain an excellect working relationship with internal IT department and troubleshoot system issues
  • Raise system-related quality events and support investigations
  • Identify and investigate potential system changes and support system-related Change Controls
  • Maintain excellent working relationships with system suppliers and escalate system issues
  • Author procedures and validation documentation relating to CSV
  • Perform validation & re-validation activities for computer systems, including risk assessments
  • Support periodic system reviews for implemented systems and provide metrics for system performance

Key Performance Indicators

  • General maintenance of GxP systems is performed in a timely manner
  • GxP systems are maintained in a validated state throughout deployment and upgrades
  • GxP system users are appropriately trained on implemented systems
  • Internal technical support calls for GxP system are handled in a timely manner and escalated appropriately

Key Job Competencies

  • Maintain GxP systems in compliance with EU, GAMP and FDA GxP requirements
  • Execute activities related to Computer Systems Validation
  • Excellent communicator with the ability to deliver technical information to non-technical personnel with varying IT competencies
  • Approachable and professional manner
  • Effective written communicator, able to deliver concise documentation, adapting writing style to audience as appropriate
  • Effectively manage changes in accordance with Change Control processes

Job Background

  • Educated to degree level in Human Health, Sciences or equivalent
  • Minimum of 3 years experience working in a GxP environment with focus on IT compliance and CSV
  • IT literate with experience maintaining GxP IT systems
  • Knowledge of GxP regulations and guidelines relating to computer systems
  • English language required

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