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Regulatory strategy planning. Regulatory compliance verification for the products (GLP, GMP; gap analysis). Preparation of response documents to the deficiency letters of health...
Management of audit and inspection findings; Develop and maintain a quality management plan; Review and revise client PSMFs in collaboration with the QPPVs, as required; Provide...
Accountable for all activities of site related study execution of assigned studies/Monitors involving start-up, execution, and close-out. Accountable for the on-time and within...