QA Auditor - BA/BE

Advity Research; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

A clinical research organization in Hyderabad is seeking a clinical auditor with BA/BE process knowledge. The ideal candidate will conduct clinical BA/BE study audits, review key clinical data, and support regulatory audits. Applicants should have strong analytical skills and a proactive mindset. This role offers an opportunity to contribute to quality management system improvements and work closely with clients. Candidates with relevant qualifications are encouraged to apply.

Qualifications

• Clinical domain knowledge required for BA/BE processes.
• Strong analytical skills and proactive approach.

Responsibilities

• Conduct clinical BA/BE study audits.
• Review PK & Statistic data, CDISC data.
• Review draft Protocols, ICD, CRF, and Clinical Study reports.
• Conduct System and Vendor audits.
• Review clinical draft SOPs.
• Facilitate client/regulatory audits.
• Review client audit responses.
• Provide inputs for client RFI.
• Identify gaps and contribute to QMS improvement.

Skills

Analytical skills

Proactive thinking

Education

BA/BE in a relevant field

Job description

• BA/BE Process clinical domain knowledge required.
• 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.