QA Manager
Share
Job Location:
Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Sr. QA Manager : 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
Role includes
Internal audits : 15%
Facing external audits : 15%
Managing CAPA QMS : 30%
Clinical monitoring reviews and oversight : 15%
Miscellaneous QA jobs: 25%
Required Skills:
ob 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 Role includes Internal audits : 15% Facing external audits : 15% Managing CAPA QMS : 30% Clinical monitoring reviews and oversight : 15% Miscellaneous QA jobs: 25%
