CSV Coordinator

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jisji

ppFor an international life science company we are looking for a: /p h3CSV Coordinator /h3 h3Responsibilities /h3 ul liMaintain and continuously improve the Integrated Management System (IMS), ensuring its effectiveness and readiness for internal, client, and regulatory audits. /li liCoordinate the management of customer complaints from initiation through resolution, partnering with relevant stakeholders to ensure timely closure. /li liOversee deviations and incident management activities, including investigation, impact assessment, corrective actions, and closure. /li liEnsure the effective implementation and monitoring of Corrective and Preventive Action (CAPA) processes. /li liSupport compliance of business processes with applicable quality standards, GxP requirements, and regulatory expectations. /li liPlan and execute internal audits and support external audit activities, engaging subject matter experts where appropriate. /li liManage quality records and documentation, ensuring appropriate archiving, retention, and traceability practices. /li liCollaborate with cross-functional teams in supplier qualification, assessment, and ongoing monitoring activities. /li liOversee 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. /li liCoordinate risk assessment activities related to GxP systems used within clinical development and regulated environments. /li liReview and manage system changes,



ensuring appropriate impact assessments, documentation, testing, and approvals are completed. /li liEnsure the integrity, traceability, and controlled management of GxP documentation and validation records. /li liRepresent the Computerized System Validation (CSV) and Quality function during client audits, regulatory inspections, and qualification assessments. /li liContribute to the development and continuous improvement of procedures, work instructions, guidelines, and best practices related to Quality Assurance, CSV, and regulated clinical operations. /li liPartner with operational and project teams to ensure quality and compliance requirements are embedded within clinical trial support processes and computerized systems. /li /ul h3Your Profile /h3 ul liBachelor Degree in Computer Science or Biomedical Engineering /li liAt least 5 years of experience as CSV and/or QA specialist in Life Science/Health industry /li liFluent in English /li /ul p“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). /p pThe 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.” /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jisji