IT Quality Specialist (F/M/D)

☞ Evotec

View: 101

Update day: 01-06-2024

Location: Abingdon South East

Category: Information Technology Pharmaceutical / Chemical / Biotech

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Job content

IT Quality Specialist
PERMANENT CONTRACT
General Summary :
The IT Quality Specialist role is to assist the IT Quality Group Leader in the operational activities for all technology-related compliance activities across the organization for GxP compliance activities and Periodic review for GxP systems and Information Technology General Controls (ITGCs)
Working with IT Team on existing IT quality processes to ensure that the IT function delivers secure, robust, and compliant systems and services.
Missions and responsibilities :
  • Perform the reviews of existing processes and documentation. Identify gaps against requirements then author and implement for all processes and services.
  • Under the guidance of the IT Quality Group Leader, Operate, Review and maintain Quality processes in support of Computerised Systems Validation and qualification such as;
  • Periodic Review of GxP Systems
  • Change Control
  • Incident / Problem management
  • IT CAPA
  • Perform risk assessments as required for IT infrastructure, applications, and support processes, documenting, and resolving any findings
  • Support processes and documentation within the IT function for GxP activities
  • Periodic review of ITGC activities (Back Up, Access Management, Disaster Recovery planning and testing)
  • Support IT Quality Group Leader for the maintenance of IT policies, Directives, SOPs and WIs
  • Develop and Maintain IT Systems Register
  • Support Validation activities
  • Assist in the implementation of a new IT quality Framework
  • Support the IT Quality infrastructure including change control, configuration management, deviation management and reporting, document management, training coordination, gap analyses and risk analyses and management
  • Implementing GAMP5 guidelines as appropriate and review of documentation for compliance to GAMP5
  • Review of documents for IT systems installations and implementation (DQ/IQ/OQ/PQ), test plans/scripts, validation summary reports
  • Generation, review and approval of Quality and Validation documentation
  • Acting as a Subject Matter Expert (SME)and guidance on Quality/ GxP Issues with special reference to validation
  • Support IT Quality Group Leader in the of Regulatory and customer Inspections
  • Support IT Quality Group Leader in the running of the GxP in-house Training Programme
  • Providing support to project teams on IT quality / regulatory issues
  • Ensure work is carried out according to GMP/GLP standards as defined in the ICH Guidelines, EC Directives, FDA regulations and local laws
  • Promote continual improvement on internal Quality systems
  • Minimal cover to support when IT Quality Group Leader is unavailable
Knowledge, skills and abilities :
Essential
Minimum 2 years’ experience working in the life sciences / pharmaceutical industry
Exposure to working with Quality management systems, specifically GxP and/or 21 CFR part 11/GAMP
Exposure to or awareness of quality management process such as ISO9001 and ISO27001
Strong communication skills (written and oral), particularly with government/legal agencies and external/internal auditors
Proven communication skills
Desirable
Demonstrated ability to apply IT-related knowledge and experience in solving compliance issues
Proven capability in writing documentation
Awareness/Certification in ITIL processes
Understanding of computer systems and integration capabilities.
Ability to translate understanding of the organisation’s goals and objectives into compliance requirements
Solid understanding of project management principles
Experience and education :
Undergraduate degree in the field of computer science, business administration or similar; graduate degree in one these fields or previous employment-based experience
Other information :
Flexible working is allowed but successful candidate will be required to be onsite at least 2 days a week
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
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Deadline: 16-07-2024

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