About Adryan
Adryan is a consultancy group comprised of approximately 150 highly skilled professionals working within the Life Sciences industry. Our offices are strategically located in the Netherlands, with headquarters in Dordrecht, as well as a branch in Leiden, and we also have a presence in Switzerland. Our consultants are engaged with various clients across Western Europe. We are committed to Quality, Connectivity, Knowledge Sharing, and Value Addition, fostering an environment where humor, lightheartedness, and craftsmanship are integral to our daily operations.
Role Overview
The role is centered on ensuring data integrity and compliance of GxP computerized systems utilized in pharmaceutical manufacturing. This position emphasizes adherence to EU GMP Annex 11, effective management of audit trails, access management, and maintaining inspection readiness in accordance with Swissmedic, EU GMP, and global regulatory requirements.
Key Responsibilities
- Act as a Subject Matter Expert (SME) for data integrity concerning computerized systems in GMP manufacturing.
- Ensure compliance with EU GMP Annex 11 and principles of data integrity (ALCOA+).
- Conduct data integrity risk assessments, gap analyses, and manage Corrective and Preventive Actions (CAPA).
- Define and oversee audit trail configurations, reviews, and trending activities.
- Support Computer System Validation (CSV) activities and system lifecycle management.
- Assist and participate in inspections by Swissmedic and the EU.
- Develop Standard Operating Procedures (SOPs) and provide data integrity training.
- Collaborate effectively with Quality Assurance, IT, Validation, Manufacturing, and Quality Control (QC) teams.
Requirements
- Degree in Life Sciences, Engineering, IT, or a related field.
- Minimum of 5 years of experience in Data Integrity, Quality Assurance, Computer System Validation, or GxP compliance.
- Strong understanding 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 skills.
Application Process
To apply for this exciting opportunity, please Apply online using the form below. Only applications matching the job profile will be considered.