Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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