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IT Quality Specialist
il y a 2 semaines
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
- 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
- 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.
