QA Auditor - BA/BE

Advity Research; Hyderabad; Presencial; INR 1 200 000 - 1 800 000; Tempo integral

Resumo da oferta

A clinical research organization in Hyderabad is looking for a professional with BA/BE process clinical domain knowledge. The role involves conducting clinical study audits, reviewing various clinical documents and data, and facilitating regulatory audits. Candidates should possess strong analytical skills and proactive thinking to identify gaps and contribute to quality management system improvement.

Qualificações

• BA/BE process clinical domain knowledge required.
• Good analytical skills and proactive thinking.

Responsabilidades

• 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 Responses.
• Provide inputs for client RFI.
• Identify the gaps and contribute for QMS improvement.

Conhecimentos

Clinical BA/BE knowledge

Analytical skills

Descrição da oferta de emprego

• 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.