Clinical QA Auditor

3 days ago


Hyderabad, India Advity Research Full time

Hyderabad 2 to 6 years Full Time

Education Qualification: B.Pharm/ M.Pharm/ M.Sc

Roles and Responsibilities:

- Plan, conduct BA/BE study audits (In process and Retrospective) in compliance with the protocol, SOPs and applicable GxP standards and regulations.
- Review of draft protocols, study ICFs and study CRF in line with applicable GxP standards and regulations.
- Review of eCTD and Clinical study report
- Provide document review comments in a timely manner.
- Issue audit reports to the auditee, review and assess the audit responses/CAPA and closure of the audit report in a timely manner.



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