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 Assurance, CSV, and regulated clinical operations.
- Partner with operational and project teams to ensure quality and compliance requirements are embedded within clinical trial support processes and computerized systems.

Your Profile

- Bachelor Degree in Computer Science or Biomedical Engineering
- At least 5 years of experience as CSV and/or QA specialist in Life Science/Health industry
- Fluent in English

“Candidates, in compliance with Legislative Decree 198/2006, 215/2003 and 216/2003, are invited to read the privacy notice available below the data request form on the application page (EU Regulation No. 2016/679).

The job offer is open to candidates of all genders, in compliance with Legislative Decree 198/2006 and current regulations on equal opportunities. The company promotes an inclusive work environment and ensures equal opportunities for all individuals, regardless of gender, age, origin, sexual orientation or disability.”

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📌 CSV Coordinator (Milano)
🏢 LHH
📍 Milano