Senior Consultant Quality DI Review - Qualification Documentation and Process Equipment Focus.

We are seeking experienced Senior Consultants to support a pharmaceutical client in Greenville, NC, with a primary focus on retrospective Data Integrity review for sterile products’ manufacturing.

Key Responsibilities

∙Conduct comprehensive retrospective review of GMP documentation and historical data .

∙Review and assess qualification and validation documentation for manufacturing

equipment, systems, utilities, processes, and associated validation/qualification records.

Including URS, IQ, OQ, PQ, commissioning documentation, protocols, reports, deviations,

and associated change controls, to determine whether equipment and processes were

appropriately qualified and remain in a validated state.

∙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 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 .

∙Evaluate process equipment and manufacturing systems used in sterile product

manufacturing, including equipment qualification records, operating parameters, alarms,

controls, maintenance/calibration records, and associated procedures, and assess their

potential impact on product quality, data integrity, and sterility assurance

Required Experience

∙7+ years of pharmaceutical/GMP experience , preferably in sterile manufacturing.

∙Strong expertise in Data Integrity and Quality Compliance .

∙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

program is highly desirable.

∙Experience reviewing equipment and process qualification documentation, including

IQ/OQ/PQ and associated validation records, deviations, change controls, and requalification

activities