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Job description
We are seeking experienced Senior Consultants to support a pharmaceutical client in Greenville, NC, with a primary focus on retrospective Data Integrity review, Sterility Assurance, and GMP Quality within sterile products' manufacturing.
Key Responsibilities
Conduct comprehensive retrospective review of GMP documentation and historical data processes, and associated validation/qualification records.
Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements .
Identify potential data integrity, GMP, and compliance gaps and assess their potential impact on product quality, GMP compliance, and sterility assurance .
Review relevant batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerized system records.
Support investigations, root cause analysis, impact assessments, and remediation activities related to the FDA 483 observations.
Clearly document findings, rationale, and recommendations in an inspection-ready format .
Demonstrated experience supporting Sterility Assurance and GMP Quality activities within
Required Experience
6+ years of pharmaceutical/GMP experience , preferably in sterile manufacturing.
Strong expertise in Data Integrity, GMP Quality Compliance, and Sterility Assurance .
Proven experience with retrospective data reviews and FDA remediation .
Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA .
Previous experience supporting an FDA inspection, Form 483 response, or remediation .
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Worksite address
greenville, NC, 27834, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.