Experteer Overview Scopra esattamente quali competenze, esperienze e qualifiche sono necessarie per avere successo in questo ruolo prima di candidarsi. In this role, you ensure product quality and regulatory compliance across pharmaceutical manufacturing operations. You will work within the Quality team to uphold GMP standards and support production of life-changing medicines. You collaborate with cross-functional groups to refine manufacturing instructions and manage master data, driving improvements and ensuring validated product documentation. This position offers the opportunity to impact quality systems, support regulatory readiness, and work on meaningful, global outcomes. Retribuzione / Benefits Follow SOPs and regulatory requirements for site products Collaborate with Production,
Tech Transfer and Quality to create/revise manufacturing instructions Manage master data and MBRs through the PMX system Process minor change requests to improve master batch records Support introduction of new products and modification of validated product documents Tailored tasks based on experience level and abilities Responsabilità 2 years of experience in pharmaceutical quality assurance or GMP environment GMP knowledge and FDA guidelines Expertise in batch record review, deviation investigations and CAPA management Strong understanding of aseptic manufacturing processes and controls Advanced proficiency in quality documentation systems (TrackWise, Documentum) Professional written and spoken communication xrdztoy Ability to manage multiple priorities in a dynamic environment Cross-functional collaboration and team development experience Proficiency with Microsoft Office applications Experience supporting regulatory inspections and customer audits Root cause analysis and quality improvement tools Knowledge of clean room operations and gowning procedures (preferred) Ability to understand and interpret technical procedures and specifications #J-18808-Ljbffr
📌 BRR and Disposition Quality Specialist (Italia)
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📍 Italia