- 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

📌 Senior Executive QA (Hyderabad)
🏢 Makro Group
📍 Hyderabad