For an international life science company we are looking for a:
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CSV Coordinator
Responsibilities
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- 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 inspectio
📌 CSV Coordinator (Milano)
🏢 LHH
📍 Milano