3 - 8 years
4 - 9 Lacs
Posted:3 days ago|
Platform:
Work from Office
Full Time
MSc/ Mpharm with 2- 8 years of relevant experience.
1.Responsible for developing, establishing and maintaining QA procedures related to clinical trials to ensure compliance to applicable regulatory guidelines.
2. Review of Clinical Trial related documents like Investigators Brochure, Clinical Trial Protocol, Informed Consent Document, associated plans and manuals. 3. Ensuring the conduct of clinical trials as per applicable guidelines, SOPs and protocols 4. Responsible for planning, conducting and reporting of audits pertaining to study. 5. Conduct of facility audits for its compliance and for ensuring CAPA implementation 6. Conduct of site audits and TMF audits as per study protocol, to generate reports and ensure CAPA implementation for the same. 7. Responsible for the external audits/inspections and its CAPA resolutions and implementation
Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)
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