About Adryan
Adryan is a consultancy group comprised of approximately 150 high-end professionals operating in the Life Sciences industry. Our offices are strategically situated in the Netherlands (Dordrecht, HQ and Leiden) and Switzerland. Our consultants collaborate with various clients across Western Europe, embodying our core values of Quality, Connectivity, Knowledge Sharing, and Value Addition. We foster an environment where humor, levity, and craftsmanship thrive in our daily operations.
Role Overview
This role is responsible for ensuring the integrity and compliance of GxP computerized systems utilized in pharmaceutical manufacturing. The position emphasizes adherence to EU GMP Annex 11, audit trails, access management, and inspection readiness, aligning with Swissmedic, EU GMP, and global regulatory requirements.
Key Responsibilities
- Act as a Data Integrity Subject Matter Expert (SME) for computerized systems in GMP manufacturing.
- Ensure compliance with EU GMP Annex 11 and data integrity principles (ALCOA+).
- Conduct 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.
- Assist and participate in Swissmedic / EU inspections.
- Develop Standard Operating Procedures (SOPs) and deliver data integrity training.
- Collaborate with QA, IT, Validation, Manufacturing, and QC teams.
Requirements
- Degree in Life Sciences, Engineering, IT, or a related field.
- 5+ years of 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.
- Fluent German and strong English language skills.
Apply online using the form below. Only applications matching the job profile will be considered.