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Qualified person

Ivrea
Contratto a tempo indeterminato
Experteer Italy
Pubblicato il 17 giugno
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OverviewExperteer OverviewAs a Qualified Person, you will independently oversee manufacturing processes and batch release in line with regulatory requirements and our GMP quality system. You will collaborate with Quality Control, Production, and site leadership to ensure product quality and regulatory compliance, driving improvements in processes, documentation, and CAPA. You will act as the link with health authorities, reporting significant issues and ensuring transparent lot documentation. Your role supports steady, compliant production and contributes to high-quality medicines for patients. This is an opportunity to influence quality culture and operational excellence in a leading pharmaceutical environment.Retribuzione / BenefitsCertify that each batch complies with the marketing authorization and legal requirementsAssess and release medicinal products per national legislationEnsure attestations of lot suitability are available for health authoritiesCollaborate on deviation investigations and approve related actionsEnsure proper storage of batch release documentation for authoritiesCommunicate substantial irregularities to health authorities and managementWork with Quality Control and Production on batch activitiesIdentify and propose improvements to manufacturing processes for quality, productivity and costCollaborate with Function Managers to ensure the Quality Management System is correctManage deviations, complaints, change control and CAPAResponsabilitàDegree in Pharmacy, CTF or ChemistryPrevious experience as Qualified Person in pharmaceutical sterile manufacturing (authorized certificate)Strong affinity with quality and quality issue awarenessOpen and clear collaboration and communication to ensure smooth daily operationsFluency in Italian and English
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