IT Quality Specialist (all genders)

Evotec (France) SAS; Hamburg; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in the life sciences sector is seeking an IT Quality Specialist. This role involves ensuring GxP compliance, conducting risk assessments, and maintaining IT quality processes. The successful candidate will work closely with the IT Quality Group Leader and support regulatory inspections while promoting continual improvement in internal quality systems. Ideal candidates will have experience in quality management within the pharmaceutical industry and strong communication skills.

Qualifikationen

• Minimum 2 years' experience in the life sciences/pharmaceutical industry.
• Exposure to Quality management systems, GxP, ISO9001, ISO27001.
• Certification in ITIL processes preferred.

Aufgaben

• Assist in operational activities for GxP compliance and technology-related tasks.
• Perform reviews and implement processes for Computerised Systems Validation.
• Support IT policies, documentation, and regulatory inspections.

Kenntnisse

Communication

Quality Management

Project Management

Risk Assessment

Ausbildung

Undergraduate degree in computer science or business administration

Tools

ITIL

GAMP5

Jobbeschreibung

• 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 :

• 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.
• 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.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.