Senior CSV & QA 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

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.