QA Auditor - BA/BE

Location: Hyderabad

Experience: 02 - 03

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.