About Adryan
Adryan is a consultancy group comprised of 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 diverse clients across various locations throughout Western Europe. We prioritize quality, connectivity, knowledge sharing, and value addition, fostering an environment where humor, levity, and craftsmanship are integral to 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 compliance with EU GMP Annex 11, focusing on audit trails, access management, and inspection readiness in accordance with Swissmedic, EU GMP, and global regulatory requirements.
Key Responsibilities
- Act as the Subject Matter Expert (SME) for data integrity in computerized systems within 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 configurations, reviews, and trending.
- Support CSV activities and system lifecycle management.
- Assist and participate in inspections by Swissmedic and EU regulatory bodies.
- 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.
- Fluency in German and strong proficiency in English.
Apply online using the form below. Only applications matching the job profile will be considered.