{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Executive QA","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

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