Data Integrity Expert

Permanent Consultant – Data Integrity & Computerized Systems Specialist (Annex 11) (m/f/d)

Industry: Pharmaceutical & Biotechnology

Languages:
German (mandatory), English (professional level)

Adryan is a consultancy group of approximately 150 high-end professionals operating in the Life Sciences industry. Our offices are located in the Netherlands (Dordrecht (HQ) and Leiden) and Switzerland. Our consultants work at various clients and locations throughout Western-Europe. We stand for Quality, Being connected, Sharing knowledge and Adding value. We support an environment where humour, levity and craftsmanship are always present in our day to day business.

Responsible for ensuring data integrity and compliance of GxP computerized systems used in pharmaceutical manufacturing. The role focuses on EU GMP Annex 11
, audit trails, access management, and inspection readiness in line with Swiss medic, EU GMP, and global regulatory requirements
.

• Act as Data Integrity SME for computerized systems in GMP manufacturing
• Ensure compliance with EU GMP Annex 11 and data integrity (ALCOA+)
• Perform data integrity risk assessments, gap analyses, and CAPA management
• Define and oversee audit trail configuration, review, and trending
• Support CSV activities and system lifecycle management
• Support and participate in Swiss medic / EU inspections
• Develop SOPs and deliver data integrity training
• Collaborate with QA, IT, Validation, Manufacturing, and QC teams

• Degree in Life Sciences, Engineering, IT, or related field
• 5+ years experience in Data Integrity, QA, CSV, or GxP compliance
• Strong knowledge of EU GMP Annex 11 and computerized systems
• Experience with audit trails, access management, and data lifecycle controls
• Inspection experience in GMP environments