CSV Coordinator
Pubblicato il 03-09-2026 - LHH in Milano
For an international life science company we are looking for a:
CSV Coordinator
Responsibilities
Maintain and continuously improve the Integrated Management System (IMS), ensuring its effectiveness and readiness for internal, client, and regulatory audits.
Coordinate the management of customer complaints from initiation through resolution, partnering with relevant stakeholders to ensure timely closure.
Oversee deviations and incident management activities, including investigation, impact assessment, corrective actions, and closure.
Ensure the effective implementation and monitoring of Corrective and Preventive Action (CAPA) processes.
Support compliance of business processes with applicable quality standards, GxP requirements, and regulatory expectations.
Plan and execute internal audits and support external audit activities, engaging subject matter experts where appropriate.
Manage quality records and documentation, ensuring appropriate archiving, retention, and traceability practices.
Collaborate with cross-functional teams in supplier qualification, assessment,
and ongoing monitoring activities.
Oversee validation activities for computerized systems supporting regulated processes and clinical research activities, ensuring lifecycle documentation is maintained in accordance with industry standards and internal procedures.
Coordinate risk assessment activities related to GxP systems used within clinical development and regulated environments.
Review and manage system changes, ensuring appropriate impact assessments, documentation, testing, and approvals are completed.
Ensure the integrity, traceability, and controlled management of GxP documentation and validation records.
Represent the Computerized System Validation (CSV) and Quality function during client audits, regulatory inspections, and qualification assessments.
Contribute to the development and continuous improvement of procedures, work instructions, guidelines, and best practices related to Quality Assuran