Business Quality Assurance professional responsible for supporting pharmaceutical manufacturing quality systems, ensuring compliance with GMP and regulatory standards, preparing for and participating in FDA audits, and managing manufacturing-related CAPAs and deviations. The role is a 12-month contract based in Ireland or Italy and requires substantial pharmaceutical quality experience.
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
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