IT Quality Specialist

Permanent position

Main Scope of Role:

• 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.

Key Responsibilities or Core Accountabilities:

For the Company (may include but is not limited to the following)

In support of the IT the IT Quality Specialist shall:

• 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 & Capabilities:

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 organization's goals and objectives into compliance requirements.
• Solid understanding of project management principles.

Education, and Qualifications:

• 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:

Employees must adhere to all applicable company policies and procedures.  Regular and predictable attendance is required. Willingness and ability to work non-standard business hours, such as evenings, weekends, and holidays, on an as-needed basis is required. Employees must be able to use good judgment and effectively deal with difficult situations, multiple demands and changing priorities.

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.