Main responsibility for establishing GCP requirements and maintaining accreditation according to DIN EN ISO 15189 in one of our specialist departments
Collaboration regarding the continuous development of GCP standards and quality requirements for the entire company
Consulting and support for the (specialist) departments in all GCP-related issues
Regular review of regulatory requirements and relevant guidelines
Monitoring of study-relevant processes, workflows and documentation in the department
Creation, review, approval and revision of GCP-relevant SOPs as well as support with department-specific documents
Ensuring compliance with data integrity requirements according to ALCOA+ principles, as well as monitoring audit trail concepts, interface validations, and backup and archiving strategies.
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