Business Quality Assurance (BQA)

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Title: Business Quality Assurance (BQA)

Domain : Life Science

Work Location: Ireland or Italy

Background check process to be followed: Before onboarding

Duration of contract: 12 months

Total Yrs. of Experience: Up to 12 years

Relevant Yrs. of experience: 7 to 12 years

Mandatory skills

  • Strong knowledge in GMP, cGMP, regulatory standards (21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, ICH Q7)
  • Experience in facing FDA audits associated with pharma manufacturing units
  • Hands-on experience with manufacturing processes, CAPAs, deviations etc.
  • Lead Auditor or any other compliance certifications will be beneficial