IT Quality Specialist (all genders)

Evotec; Toulouse; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player is seeking an IT Quality Specialist to enhance their quality management systems and ensure compliance with regulatory standards. In this role, you will collaborate with IT teams to maintain GxP activities, conduct risk assessments, and support the implementation of a new IT quality framework. Your expertise will guide project teams through quality and regulatory challenges, promoting continuous improvement within the organization. This is a fantastic opportunity for someone passionate about quality assurance in the life sciences sector to make a significant impact.

Qualifications

• 2+ years of experience in the life sciences or pharmaceutical industry.
• Familiarity with regulatory compliance and quality systems.

Responsabilités

• Review and improve processes and documentation for compliance.
• Support validation and qualification of computerized systems.

Connaissances

Quality management systems

GxP

21 CFR part 11

GAMP

ISO9001

ISO27001

Strong communication skills

Formation

Bachelor's degree in computer science

Graduate degree or relevant experience

Outils

ITIL certification

Description du poste

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.