Job Description
Description
Sr. Quality Specialist, Clinical Quality responsible for managing clinical quality function, ensuring compliance with local clinical trial regulatory requirements and Takeda’s Quality Management Systems.Works in collaboration with local clinical operation team ensuring adherence to Good Clinical Practice Guidance.Drives the development and implementation of CQA procedures and local QMS (including GCP compliant process development) for managing local Clinical trial quality assurance in accordance with internal procedures.Responsible as cross functional reviewer (where applicable) and quality authorizer as per internal procedures.Establishing and maintaining local risk register. Engage the key LOC stakeholders to proactively identify GxP (primary focus GCP) quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the LOC.Lead supplier and individual clinical study audit(...
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