Bioanalytical QA Auditor

3 days ago


Hyderabad, India Advity Research Full time

Hyderabad 2-6 Years Full Time

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

Roles & Responsibilities:

- Plan, conduct BA/BE study audits (In process and Retrospective) in compliance with a study plan, protocol, SOPs and applicable GxP standards/regulations.
- Review of Method Development and Method Validation data
- Review of draft Method SOPs and Bioanalytical study plan in line with applicable SOPs and GxP standards/regulations
- Review of eCTD and Bioanalytical 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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