Senior Executive QA

• 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