Quality & Compliance System Senior Specialist

27 set - Napoli
Chiesi

ppIn this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site.
You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance.
You will enable a culture of quality and continuous improvement, shaping robust processes for materials, manufacturing, and release specifications.
This is a chance to contribute to a globally recognized biopharmaceutical group focused on sustainable health outcomes.
/pullicomprehensive healthcare programs /liliwork-life balance initiatives /lilirelocation support /liliflexible working arrangements /liliremote work options /liliDevelop and implement QMS processes, procedures, and documentation to meet quality standards /liliMonitor and analyze quality data, identify trends, and drive improvement actions /liliPrepare periodic QMS performance reports for management /liliCollaborate with production, engineering, procurement and other functions to resolve quality issues /liliInvestigate quality problems, identify root causes,



and implement corrective and preventive actions (CAPA) /liliGovern and promote a culture of quality and continuous improvement across the site /liliShare best practices and ensure activities comply with company procedures /liliDegree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering) /liliAt least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology /liliExcellent knowledge of EU and FDA pharmaceutical guidelines /liliSpecialized expertise in GMP compliance improvement processes /liliFluent English (written and spoken) /liliStrong teamwork and cross-functional collaboration /liliAnalytical thinking with ability to assess technical issues and propose shared solutions /liliEffective communication and stakeholder management /liliQMS development and governance /liliQuality data analysis and trend identification /liliRoot cause analysis and CAPA implementation /li /ulpQuality Compliance System Senior Specialist napoli, campania, it /p /p #J-*****-Ljbffr

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