IT Quality Specialist (all genders)

IT Quality Specialist Permanent position Main Scope of Role: The IT Quality Specialist role is to assist the IT Quality Group Leader in operational activities for all technology-related compliance activities across the organization, focusing on GxP compliance and periodic reviews of GxP systems and ITGCs. Collaborate with the IT team to ensure the delivery of secure, robust, and compliant systems and services. Key Responsibilities or Core Accountabilities: In support of the IT department, the IT Quality Specialist shall: Review existing processes and documentation, identify gaps, and implement improvements. Assist in maintaining quality processes supporting Computerized Systems Validation, including: Periodic review of GxP systems Change control Incident/problem management IT CAPA Perform risk assessments for IT infrastructure, applications, and support processes, documenting and resolving findings. Support IT GxP activities, including documentation and process reviews. Review ITGC activities such as backups, access management, and disaster recovery testing. Assist in maintaining IT policies, directives, SOPs, and WIs. Develop and maintain the IT Systems Register. Support validation activities and the implementation of a new IT quality framework. Support IT quality infrastructure, including change control, configuration management, deviation management, and document management. Ensure documentation compliance with GAMP5 guidelines. Review validation documentation such as DQ, IQ, OQ, PQ, and validation summaries. Generate, review, and approve quality and validation documentation. Act as a Subject Matter Expert on GxP and validation issues. Support regulatory and customer inspections and in-house GxP training programs. Provide support to project teams on IT quality and regulatory issues. Ensure work complies with GMP/GLP standards, ICH guidelines, EC directives, FDA regulations, and local laws. Promote continuous improvement of internal quality systems. Provide minimal support when the IT Quality Group Leader is unavailable. Knowledge, Skills & Capabilities: Essential: Minimum 2 years' experience in the life sciences/pharmaceutical industry. Experience with GxP, 21 CFR part 11, GAMP, and quality management systems. Strong communication skills, especially with regulatory agencies and auditors. Desirable: Ability to apply IT knowledge to compliance issues. Experience in documentation writing. ITIL certification and understanding of system integration. Project management skills. Education and Qualifications: Undergraduate degree in computer science, business administration, or related field; graduate degree or relevant experience preferred. Other Information: Adherence to company policies, regular attendance, and flexibility for non-standard hours are required. Ability to handle challenging situations and prioritize effectively is essential. In accordance with our Diversity policy, Evotec considers all applications equally, including those from people with disabilities. J-18808-Ljbffr

Location: verona, IT

Posted Date: 5/12/2025