IT Quality Specialist
il y a 15 heures
IT Quality SpecialistPosition Type: PermanentMain Scope of Role:The IT Quality Specialist assists the IT Quality Group Leader with operational activities related to technology compliance, GxP activities, and periodic reviews of GxP systems and ITGCs.Collaborates with the IT team to ensure quality processes support secure, robust, and compliant systems and services.Key Responsibilities or Core Accountabilities:For the Company (may include but is not limited to):Review and improve existing processes and documentation, identifying gaps and implementing necessary updates.Support computerised systems validation and qualification, including periodic review, change control, incident/problem management, and IT CAPA.Perform risk assessments on IT infrastructure, applications, and support processes, documenting and resolving findings.Maintain IT quality processes supporting GxP activities and review ITGC activities like backup, access management, and disaster recovery.Assist in maintaining IT policies, directives, SOPs, and work instructions.Develop and maintain an IT Systems Register and support validation activities.Support the implementation of a new IT quality framework and related infrastructure activities.Ensure documentation compliance with GAMP5 guidelines, including DQ/IQ/OQ/PQ documentation and validation reports.Act as a Subject Matter Expert (SME) on Quality/GxP issues, especially validation.Support regulatory and customer inspections and the GxP in-house training program.Provide guidance to project teams on IT quality and regulatory issues.Ensure work adheres to GMP/GLP standards per ICH, EC, FDA, 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:At least 2 years' experience in the life sciences or pharmaceutical industry.Experience with Quality management systems, GxP, 21 CFR part 11, GAMP.Familiarity with ISO9001 and ISO27001.Strong written and oral communication skills, especially with regulatory agencies and auditors.Desirable:Ability to apply IT knowledge to compliance issues.Skilled in documentation writing.ITIL certification or knowledge.Understanding of computer systems and integration.Capability to translate organizational goals into compliance requirements.Basic project management understanding.Education and Qualifications:Bachelor's degree in computer science, business administration, or similar; a graduate degree or relevant experience is preferred.Other Information:Adherence to company policies and procedures is required. Must be available for non-standard hours as needed. Must use good judgment in handling difficult situations 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. #J-18808-Ljbffr
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IT Quality Specialist
il y a 2 semaines
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