Job Description

Perform maintenance of company SOPs in compliance with ICH-GCP, international and national regulations Review, approval and archival of company SOPs in compliance with ICH-GCP, international and national regulations Review and maintain company archives of clinical protocols and study documents Conduct QA internal audits of all aspects of the Clinical Research Departments activities to ensure compliance with ICH-GCP and applicable international and company procedures Perform QA reviews of protocols and other documents and data in preparation for submission to IRB/IEC, regulatory health authorities and publications Provide training to research staff on GCP, ICH and local regulations (as required) Generate, maintain and manage documents and training records of the activities of the Clinical Research Department Document Control & Issuance Preparation of Master Index to all QAU files & Documents Filling of all Master documents after approval in a sequential way so that it can be easily identified Skills and Knowledge needed on the following guidelines ICH-GCP ISO9001:2015 ISO14155:2011 ISO13485:2016