IT Quality Specialist (all genders)

IT Quality Specialist

Position Type: Permanent

Main 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.