About Adryan
Adryan is a consultancy group comprising approximately 150 high-end professionals operating within the Life Sciences industry. Our offices are strategically located in the Netherlands (Dordrecht - HQ and Leiden) and Switzerland. Our consultants engage with various clients across multiple locations throughout Western Europe. We pride ourselves on our commitment to quality, connectivity, knowledge sharing, and value addition. In our work culture, we foster an environment where humor, levity, and craftsmanship are integral to our daily operations.
Role Overview
The role is primarily responsible for ensuring data integrity and compliance of GxP computerized systems used in pharmaceutical manufacturing. It focuses on EU GMP Annex 11, audit trails, access management, and inspection readiness in accordance with Swissmedic, EU GMP, and global regulatory requirements.
Key Responsibilities
- Act as a Subject Matter Expert (SME) for data integrity in GMP manufacturing computerized systems
- Ensure compliance with EU GMP Annex 11 and uphold data integrity (ALCOA+)
- Conduct data integrity risk assessments, gap analyses, and CAPA management
- Define and supervise audit trail configuration, review, and trending
- Support CSV activities and oversee system lifecycle management
- Assist in and participate in Swissmedic / EU inspections
- Develop Standard Operating Procedures (SOPs) and provide data integrity training
- Collaborate with Quality Assurance (QA), IT, Validation, Manufacturing, and Quality Control (QC) teams
Requirements
- Degree in Life Sciences, Engineering, Information Technology, or a related field
- 5+ years of experience in Data Integrity, Quality Assurance (QA), Computer 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
- Experience with inspections in GMP environments
- Fluent in German and possess strong English language skills
Application Process
To explore this exciting opportunity, apply online using the form below. Please note that only applications matching the job profile will be considered.