CSV Coordinator

LHH; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

LHH is seeking an experienced CSV Coordinator to join our international life sciences team in Milan. You will manage the Integrated Management System, coordinate CSV/QA activities, and support audits, CAPA, and regulatory expectations.

The ideal candidate holds a Bachelor’s degree in Computer Science or Biomedical Engineering, 5+ years in CSV/QA within Life Science, and fluent English. This role offers collaboration across cross‑functional teams and exposure to regulated clinical operations.

Competenze

• Bachelor's degree in Computer Science or Biomedical Engineering.
• Minimum 5 years of experience as CSV and/or QA specialist in Life Science/Health.
• Fluent in English.

Mansioni

• Maintain and improve the Integrated Management System (IMS), and ensure readiness for audits.
• Coordinate management of customer complaints from initiation to resolution.
• Oversee deviations, incidents, CAPA processes, and lifecycle documentation.
• Support GxP compliance and regulatory expectations across processes.
• Plan and execute internal audits and assist external audits.
• Manage quality records, archiving, retention, and traceability.
• Collaborate with cross-functional teams on supplier qualification and monitoring.
• Oversee validation activities for computerized systems supporting regulated processes.

Conoscenze

CSV knowledge

QA experience

English fluent

Formazione

Bachelor in CS or BioEng

Descrizione del lavoro

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.”