Data Integrity Expert

About Adryan

Adryan is a consultancy group comprising around 150 high-end professionals dedicated to the Life Sciences industry. With offices in the Netherlands (Dordrecht and Leiden) and Switzerland, our consultants collaborate with various clients across Western Europe. We prioritize quality, connectivity, knowledge sharing, and adding value, fostering a work environment characterized by humor, craftsmanship, and a light-hearted approach to day-to-day operations.

Role Overview

The individual will be responsible for maintaining data integrity and compliance within GxP computerized systems associated with pharmaceutical manufacturing. This position emphasizes adherence to EU GMP Annex 11, audit trails, access management, and ensuring readiness for inspections in accordance with Swissmedic, EU GMP, and global regulatory standards.

Key Responsibilities

• Serve as the Subject Matter Expert (SME) for data integrity related to computerized systems in GMP manufacturing.
• Ensure compliance with EU GMP Annex 11 and uphold data integrity principles (ALCOA+).
• Conduct data integrity risk assessments, gap analyses, and implement CAPA management.
• Define and manage audit trail configuration, review, and trending activities.
• Support Computer System Validation (CSV) processes and oversee system lifecycle management.
• Assist in preparation for and participation in Swissmedic and EU inspections.
• Develop Standard Operating Procedures (SOPs) and deliver training on data integrity.
• Collaborate effectively with Quality Assurance (QA), Information Technology (IT), Validation, Manufacturing, and Quality Control (QC) teams.

Requirements

• Degree in Life Sciences, Engineering, IT, or a related field.
• 5+ years of experience in Data Integrity, Quality Assurance, Computer System Validation (CSV), or GxP compliance.
• Strong understanding of EU GMP Annex 11 and computerized systems.
• Experience in audit trails, access management, and data lifecycle controls.
• Familiarity with inspections in GMP environments.
• Fluency in German and strong competency in English.