QA Auditor

1 week ago


Hyderabad Telangana, India Advity Research Full time

**Location**: Hyderabad

**Experience**: 04 - 05

**Qualifications & Other Specifics**:
**Qualifications**:

- M.Pharm

**Preferred Skills**:

- Communication skills (Written/Oral).
- Attention to details.
- Teamwork and collaboration.
- Ability to work independently.
- BA/BE Process clinical domain knowledge required.
- Computer skills (MS-Word & Excel).
- Good analytical skills and proactive thinking.

**Detailed Responsibilities**:

- Conduct of Clinical BA/BE study audits.
- Review of PK & Stat data, CDISC data.
- Review of draft Protocols, ICD, CRF and Clinical Study report.
- Conduct of System and Vendor audits.
- Review of clinical draft SOPs.
- Facilitating in support for client/regulatory audits.
- Review of client audit Reponses.
- Provide inputs for client RFI.
- Identify the gaps and contribute for QMS improvement.



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