Job Description

We’re Hiring @Aurigene Oncology Limited, Bangalore

Role: Clinical Trial- QA

Education: MPharm/ MSc Experience: 4 to 9 years

Job Description:  

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 it’s CAPA resolutions and implementation

Interested & relevant candidates can share their resume at sushmitha@aurigene.com