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Head of R&D Quality Assurance


Head of R&D Quality Assurance



Soggetto:Head of R&D Quality Assurance
Luogo: Pambio-Noranco
Azienda: Helsinn Healthcare SA
Data: 2019-01-06



Dettagli dell'annuncio di lavoro Head of R&D Quality Assurance

Descrizione: For our Scientific Operations Division in Lugano we are looking for a: HEAD OF R&D QUALITY ASSURANCE Responsibilities include: Assure the implementation and maintenance of an effective and efficient Quality Management System in accordance with the GXP rules and regulations (GCP, GMP, GLP and GVP) and Helsinn Group Quality Manual Formulate GXP compliance strategy and provide advice for all programs in collaboration with key stakeholders and Group QA Assess GXP compliance risk areas and develop and implement risk mitigation measures Manage QA reviews of essential R&D documents as well as regulatory authority inspections Ensure appropriate evaluation of service providers as part of the vendor selection process Provide compliance guidance to audited parties and serve as an expert in the interpretation of GCP, GMP, GLP and GVP regulatory requirements and expectations Plan and lead GXP compliance audits, develop and prioritize audit strategies Report audit findings as well a



Luogo di lavoro: Pambio-Noranco via Pian Scairolo, 6915 Pambio-Noranco