Job Title: QA Auditor – BA/BE
Location: Hyderabad
Experience: 4 – 5 Years
Qualifications & Eligibility:
Education: M.Pharm
Preferred Skills:
Strong written and oral communication skills
Sharp attention to detail
Effective team collaboration and independent working abilities
Sound knowledge of BA/BE clinical processes
Proficient in MS Word and Excel
Strong analytical thinking and proactive approach
Key Responsibilities:
Conduct audits of Clinical BA/BE studies to ensure protocol and regulatory compliance
Review of Pharmacokinetic (PK) and Statistical data, including CDISC datasets
Evaluate draft protocols, Informed Consent Documents (ICD), Case Report Forms (CRF), and Clinical Study Reports (CSR)
Perform system audits and vendor audits
Review and assess clinical SOPs (Standard Operating Procedures)
Support client and regulatory audits by providing relevant documentation and guidance
Review and contribute to client audit responses
Provide detailed input for Request for Information (RFI) responses
Identify gaps in processes and actively contribute to QMS (Quality Management System) improvements
Preferred Candidate Profile:
Familiarity with regulatory requirements and GCP
Audit experience in the clinical BA/BE domain
Ability to manage timelines and collaborate with cross-functional teams
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