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Qa Auditor - Ba/Be

2-3 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: M.Pharm Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

QA Auditor – BA/BE

Location:

Hyderabad, India

Experience Required:

2 – 3 years


Qualifications & Specifics

Education:

  • M.Pharm

Preferred Skills:

  • Strong written and oral communication skills

  • Sharp attention to detail

  • Excellent teamwork and collaboration abilities

  • Ability to work independently

  • Sound clinical domain knowledge in BA/BE processes

  • MS Word and Excel proficiency

  • Solid analytical skills and proactive thinking


Detailed Responsibilities:

  • Conduct audits of Clinical BA/BE studies

  • Review Pharmacokinetic (PK), Statistical, and CDISC data

  • Evaluate draft Protocols, Informed Consent Documents (ICDs), Case Report Forms (CRFs), and Clinical Study Reports

  • Perform system audits and vendor audits

  • Review clinical draft SOPs

  • Support client and regulatory audits

  • Review and respond to client audit reports

  • Provide input for client RFIs (Requests for Information)

  • Identify process gaps and contribute to QMS improvements