Data Integrity Consultant: 21 CFR Part 11 & GxP Compliance

Trevalco; Antwerpen; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

Trevalco is seeking a data integrity consultant to join our pharmaceutical client projects. You will assess systems for compliance with 21CFR Part 11, Eudralex annex 11, and internal requirements, identify gaps, and draft action plans.

The role requires English and Dutch fluency, strong analytical skills, and experience in ICT quality assurance within pharma. You will work independently, balance quality, budget, and schedule, and support risk assessments and quality investigations.

Qualifications

• Fluent in English and Dutch
• Strong analytical skills, well organized, studious and precise
• A first experience in an ICT quality assurance position or a similar position in the pharmaceutical industry
• Patient with people, capable of gaining their trust and collecting the information needed to complete your work
• You can work independently and capable of standing your ground when challenged
• Commercial attitude, able to convince clients by communicating clearly and enthusiastically

Responsabilités

• execute data integrity compliance / gap assessments
• write technical reports
• participate to improvement projects
• manage quality records such as deviations, CAPA's and change controls
• participate to risk assessments and quality investigations
• ensure compliance to and advice the client on regulatory requirements, industry trends related to data integrity
• take decisions which properly balance out quality / budget / planning and help stakeholders to reach a compromise on critical quality decisions

Connaissances

Fluent in English and Dutch

Strong analytical skills

Well organized

Studious and precise

Independent worker

Formation

Master's degree in science/IT/engineering

Equivalent through experience

Outils

ALCOA knowledge

GAMP knowledge

Description du poste

Trevalco is seeking a data integrity consultant to join our pharmaceutical client projects. You will assess systems for compliance with 21CFR Part 11, Eudralex annex 11, and internal requirements, identify gaps, and draft action plans.

The role requires English and Dutch fluency, strong analytical skills, and experience in ICT quality assurance within pharma. You will work independently, balance quality, budget, and schedule, and support risk assessments and quality investigations.