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You will act as a trusted quality and compliance advisor. You will help teams navigate complex regulatory requirements, strengthen quality processes, manage risk and continuously improve the way clinical trials are delivered. Monitor the regulatory
Drive biomarker testing strategies across multiple clinical trial programs as well as diagnostic and companion diagnostic (CDx) initiatives; Act as a scientific expert in selecting fit-for-purpose analytical technologies such as LC-MS...
Lead and develop a multidisciplinary team of process engineers, specialists, and manufacturing professionals, fostering a culture of safety, quality, accountability, and continuous improvement. Take ownership of operational performance within the DSP
Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM; Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs;
Root cause analysis (RCA) and CAPA implementation for project topics, and general lab topic. Investigation and management of deviations, as Lead Investigator. Quality oversight and audit readiness in GMP-regulated labs (participation in audits for
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