Business Quality Assurance (BQA)

Overview

Remote
Depends on Experience
Contract - Independent
Contract - W2
No Travel Required

Skills

GMP
cGMP
BQA
FDA audits

Job Details

Mandatory Skills & Qualifications:

  1. Strong knowledge in GMP, cGMP, and regulatory standards:
    • 21 CFR Part 11
    • 21 CFR Part 210
    • 21 CFR Part 211
    • ICH Q7
  2. Experience facing FDA audits at pharmaceutical manufacturing sites
  3. Hands-on experience with manufacturing processes, CAPAs, deviations, etc.
  4. Lead Auditor or any other compliance certifications (preferred)
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