Sr. QA Manager
Makro Group · Hyderabad · onsite · Posted 33d ago
Undisclosed8–12 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- 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: Quality Assurance
- Other Industry Type: Clinical Research / Contract Research Department: Quality Assurance Employment Type: Full Time, Permanent Role Category: Quality Assurance
- Location-Madhapur, Hyderabad, TS, India
Sourced from naukri
Skills
QAclinical researchgoogle cloud platformQuality AssuranceResearchmaintenancecompliance
About Makro Group

Makro Group
IT Services & Consulting
Hyderabad / Secunderabad, Telangana
India
₹10.8L PA avg
Avg at Makro Group
About
Makro Group unique ability is to see the big picture. With experts in every aspect of life cycle, we offer several services to provide a comprehensive perspective on the challenges you face, and build innovative solutions to address them.So, whether you need a single service or a broad initiative that integrates a variety of disciplines, we can help. We invite you to explore the rest of our site and divisions of Makro Group.
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ConsultingHealth CareInformation TechnologyLife SciencePharmaceuticalStaffing Agency
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