Information Systems Quality Representative

  • Job Reference: HQ00016147
  • Date Posted: 9 April 2019
  • Recruiter: E-Resourcing
  • Location: Basingstoke
  • Salary: £22.43 to £40.26
  • Sector: IT (general)
  • Job Type: Contract
  • Duration: 12 months
  • Work Hours: Full Time

Job Description

We are currently looking to recruit an Information Systems Quality Representative for a global Pharmaceutical Company.

  • Position: ISQ Representative
  • 12-month Contract, expected to extend for a further 12 months
  • Location: Basingstoke
  • Rate: £40 p/hr dependant on experience­­­­

Job Description

  • Responsible for ensuring functional areas, projects, and/or systems are in compliance with Computer System Validation (CSV) standards
  • Provide independent compliance and quality oversight for the areas they support
  • Implement a risk-based approach for validating computer systems or qualifying platforms

Core responsibilities

  • Drive compliance culture within the business
  • Build key relationships
  • Participate in self-inspections and audits
  • Provide periodic status and compliance updates to IT areas
  • Understand customer, company, and quality priorities
  • Consult with Functional Areas regarding Quality Management System components
  • g.,
    • Periodic reviews
    • Personnel qualification
    • Document Management
    • IT Privacy & Information Security
    • CAPA Management

  • Provide leadership and guidance
  • Understand and communicate the value of CSV
  • Orchestrate the creation and maintenance of CSV deliverables
  • Provide oversight and ensure regulated and critical systems are validated in compliance with regulations and standards for computer systems
  • Review and/or approve documents per CSV expectation within agreed service levels
  • Identify and pursue opportunities for streamlining
  • Partner with business, business quality, and IT customer areas to deliver business value
  • Grow capabilities of those performing CSV activities
  • Deliver training programs to increase understanding/knowledge of CSV

Key Requirements

  • Proficiency with IT Systems development life cycle and IT best practices (e.g. ITIL, Agile, etc)
  • Proficiency with Computer Systems Validation
  • Previous experience with implementing regulated computer systems
  • Broad IT technical competency
  • Previous experience in regulated (e.g., GMP, GLP, GCP, SOX) environment
  • Knowledge of Pharmaceutical Industry (preferable)
  • Project Management skills