About Adryan
Adryan is a consultancy group comprising approximately 150 high-end professionals dedicated to the Life Sciences industry. Our offices are strategically located in the Netherlands (Dordrecht - HQ and Leiden) and Switzerland, allowing our consultants to engage with various clients across Western Europe. We are committed to Quality, Connectivity, Knowledge Sharing, and Value Addition, fostering an environment where humor, levity, and craftsmanship thrive in our daily operations.
Role Overview
The successful candidate will be responsible for ensuring data integrity and compliance of GxP computerized systems utilized in pharmaceutical manufacturing. This role emphasizes adherence to EU GMP Annex 11, management of audit trails, access control, and maintaining inspection readiness in compliance with Swissmedic, EU GMP, and global regulatory standards.
Key Responsibilities
- Act as 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 manage CAPA processes
- Define and oversee the configuration, review, and trending of audit trails
- Support Computerized System Validation (CSV) activities and system lifecycle management
- Assist and participate in Swissmedic and EU inspections
- Develop Standard Operating Procedures (SOPs) and provide data integrity training
- Collaborate effectively 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, Quality Assurance (QA), Computerized System Validation (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 in German and possess strong English language skills
Apply online using the form below. Please note that only applications matching the job profile will be considered.