Access HR Management Consultants Pvt Ltd
Location
Mumbai | India
Job description
Intimation of stability testing and follow up of stability reports with CMOs Preparation and review of stability protocols for new studies Assuring a suitable stability study number in stability software to every study initiated (On going) Ownership of OOS/OOT investigations and ensure that the relevant agency/QP is notified immediately once the results are confirmed Unless otherwise justified, close all stability related deviation within 45 working days Reduction of deviations cycle time in stability Provide support to internal stakeholder by providing requested information on time Prepare risk assessments, justifications, expert statement and RFI response for regulatory submissions. Supports CMO's and contract labs in case of problems and arrangement of impurity /other standards. Managing the stability database on daily basis Monthly reporting of Stability Metrics to Manager (on-going)
Job tags
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