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the Clinical inspection readiness Leader (cirl) is an “ExpertLeader responsible to lead Clinical inspection readiness (ir) and pre-approval inspection (pai) activities  and to identify strategic solutions for continued improvement across .....
1. perform the routine inspections on the key steps in production area according to the sops, to ensure the routine Operations comply with the requirements of SOP, GMP and mls/pls   .....
lead continuous improvement in quality of china ma led Clinical studieslead the development and execution ofannual study/pv system qc plan which isagreed with tamd and evgen ad andpv leaderduring qc, provides in-the-momentfeedback and Coaching to .....
as a head of quality Compliance, you will be responsible for management of Compliance activities in accordance with roche policies, standards, procedures and global cgmps, establish strategic goals and objectives and maintain full strategic .....
 Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular LSOs meetings organized by corporate Patient Safety; · Ensure that the required local information for the Pharmacovigilance .....
CTOMs in China is an integrated part of Trial Operations (TO) global organization to provide operational expertise and service to Sanofi clinical development in China, Asia Pacic and global programs.The CTOM(Trial Management Track) is responsible .....
participate in the coordination of and contribute to operational (activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives from study specifications (ss) through study close-out activities and .....
This position is for a BioMarker Operations Manager / Bioanalysis Outsourcing Manager with expertise in biomarker and bioanalysis in Outsourcing and Study Monitoring, Project Operations in TMED (translational medicine and early development).  The .....
responsibilities:- to evaluate the batch production record of sterile products, in-process record- issue the qe report of sterile products- contribution on dds as qa representative- support ipc function- facilitate and support key Business Processes .....
He/she is the local lead of a  Record Management team. He/she manages and coordinates activities related to the management of records. He/she works in close collaboration with Head of Record Management team  to propose services for trial records, .....
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