QA Auditor - BA/BE

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.